Pediatr Surg Int DOI 10.1007/s00383-014-3649-9
ORIGINAL ARTICLE
The effect of audio therapy to treat postoperative pain in children undergoing major surgery: a randomized controlled trial B. S. Sunitha Suresh • Gildasio S. De Oliveira Jr. Santhanam Suresh
•
Accepted: 3 December 2014 Ó Springer-Verlag Berlin Heidelberg 2015
Abstract Purpose To evaluate the analgesic effect of music and audiobooks in children undergoing major surgical procedures when compared to a control (silence) group. Methods The study was a prospective and randomized trial. Children undergoing major surgeries were randomized to one of the three groups: music, audiobook or control (silence). The primary outcome was the pain burden reduction by two treatments within 48 h postoperatively. Pain burden was measured using the area under the pain scale versus the 30 min interval for each treatment. Results 60 patients were recruited and 56 completed the study. Pain burden was reduced in the music and audiobook groups compared to control, median (IQR) of -60 (-90 to 0), -45 (-90 to 0) and 0 (-30 to 90) (min 9 pain score), respectively, P = 0.04. A linear regression analysis demonstrated an independent group effect on pain reduction even after adjusting for the mean pain scores recorded at the beginning of the treatment, slope of regression line -56.8 ± 24 goodness of fit r2 = 0.25 and slope significantly different from 0 (P = 0.02). Conclusions Audio therapy is an efficacious adjunct method to decrease post-surgical pain in children
B. S. Sunitha Suresh G. S. De Oliveira Jr. S. Suresh Department of Pediatric Anesthesiology, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL, USA Present Address: B. S. Sunitha Suresh Johns Hopkins Medical School, Baltimore, MD, USA G. S. De Oliveira Jr. (&) Department of Anesthesiology, Northwestern University, 241 East Huron St F5-704, Chicago, IL, USA e-mail: [email protected]
undergoing major surgeries. Audio therapy should be considered as an important strategy to minimize pain in children undergoing major surgery. Keywords Music post-surgical pain Music treatment pain surgery children
Introduction The treatment of post-surgical pain in children often relies on the use of opioid analgesics [1, 2]. Due to the fear of opioid-related side effects such as respiratory depression, caregivers usually limit the amount of opioids given to children and this practice frequently results in poor postsurgical analgesic control [3–5]. In addition, the use of non-opioid drugs for pain control in children is commonly hindered by the lack of studies addressing efficacy and safety of those drugs in this patient population [6, 7]. The use of non-pharmacological therapies such as music has been evaluated with promising results to minimize pain in children [8]. Nevertheless, prior studies focused primarily in the use of music therapy to minimize pain associated with short medical procedures such as venipuncture but not for the treatment of post-surgical pain [9–11]. The distracting and anxiolytic properties of audiobooks may also have a promising effect on pain control in children undergoing surgery but their efficacy remains to be evaluated [12]. Currently, there is a lack of recommendation for non-pharmacological strategies by practice guidelines for the treatment of post-surgical pain in children [13]. The main objective of the current investigation was to evaluate the potential analgesic effect of music and audiobooks in children undergoing major surgical procedures
123
Pediatr Surg Int
when compared to a control (silence) group. We hypothesized that children exposed to music or audiobooks during the post-surgical period would have less pain than children in the control group.
Materials and methods This was a prospective, randomized and controlled study. The study was approved by the Ann & Robert H. Lurie Children’s Hospital’s Institutional Review Board. Written informed consent was obtained from the guardians of all patients and assent was also obtained from children older than 8 years of age. Children aged from 6 to 18 years scheduled for major elective orthopedic, neurosurgical, urological, plastic or general surgeries at Lurie Children’s Hospital of Chicago, USA were recruited to participate in this study. Children were excluded if they were hearing impaired, mentally challenged and if they had chronic pain or opioids use. Patients were randomized using a computer-generated table of random numbers to three groups: a music, an audiobook and a silence control group. Allocation was concealed by keeping the allocated treatment group in a sealed opaque envelope that was opened only after the child entered the study. Prior to surgery, if the patients were allocated to the music or the audiobook group, they were provided a playlist for music and a set of audiobooks to choose from. This allowed them to make their choice prior to any effects of anesthesia or surgery. The Audiobook group wore noise-canceling headphones (Etymotics; Elk Grove Village, IL, USA) connected to an iPodTM (Apple Incorporated; Cupertino, CA, USA) containing a selection of audiobooks and listened to an audiobook of their choice for 30 min. For the Music Group, a playlist from selections provided on an iPodTM was created. Children wore noisecanceling headphones and listened to their music for 30 min. The Silence control group received no intervention. The Faces Pain Scale-Revised FPS-R, a validated scale to assess pain in children of 4 or 5 years old, was used to evaluate pain. Pain scores were assessed before treatment and 30 min after treatment within 48 h after surgery. The difference between post and pre-treatment pain scores was calculated as the main treatment effect for the study. This method accounted for differences in pain intensity among distinct surgeries and differences in analgesic treatments. The primary outcome was the pain burden reduction by the two treatments. Pain burden reduction was measured by the decrement in the area under the pain scale versus the 30 min time curve for each treatment using the trapezoidal method (Graph Pad Prism version 5.03, Graph Pad Software, Inc., La Jolla, Ca) [14]. For all children, pain was
123
treated according to the standard of the institution and adapted to the specific type of surgery and age. Other data collected included age, gender, surgical type and duration of surgery. All data were collected by a single investigator (SS). In a one-way ANOVA study, sample sizes of 18, 18 and 18 will be obtained from the three groups whose means are to be compared. The total sample size of 54 subjects achieves 82 % power to detect differences with an effect size of 1 point difference in pain scores between groups and using a F test with a 0.01 significance level. The size of variation in the means is represented by their standard deviation which is 0.82. The common standard deviation within a group is assumed to be 1.5. 20 patients per group were recruited to account for possible drop outs. Power calculation was performed using PASS version 8.0.15, 2010 (NCSS, LLC, Kaysville, UT). The Shapiro–Wilk and Kolmogorov–Smirnov tests were used to test the hypothesis of normal distribution. Normally, distributed interval data are reported as mean (SD) and were evaluated by one-way ANOVA. Non-normally distributed interval data and ordinal data are reported as median [interquartile range (IRQ)] using the Kruskal– Wallis H test. Post-hoc comparisons were made using the Tukey–Kramer or Dunn’s test with Bonferroni correction for multiple comparisons [15]. Categorical variables were evaluated using the Fisher’s exact test. An additional exploratory analysis was performed by combing the audiobook and music groups (audio therapy) and median differences and 95 % confidence intervals of the differences in pain burden reduction were calculated using a 10,000 sample bootstrapping method. All reported P values are two tailed. A generalized linear regression model was also conducted to control for the treatment effect across different initial pain scores. Statistical analysis was performed using Stata version 12 (StataCorporation 2011. Stata Statistical Software: Release 12; College Station, TX: StataCorp LP.)
Results Sixty children undergoing major surgery were recruited to the study between July 2010 and December 2010. The details of the conduct of the study are presented in Fig. 1. Six patients were excluded from the final analysis. Three patients were discharged home before receiving the two interventions and three patients requested to be excluded from the study. There were no differences on baseline characteristics among the study groups (Table 1). The median (IQR) for time to the first treatment was 18.7 (17.5–20.2), 17.2 (16–23) and 18.1 (16–21.7) h for the music, audiobook and control, respectively, P = 0.96. The
Pediatr Surg Int Fig. 1 Consort flow diagram for the study
Table 1 Baseline characteristics of the study groups
Age (years)
Music (n = 18)
Audiobook (n = 17)
Control (n = 19)
10.9 (9.1–13.9)
12.9 (11.5–13.9)
12.4 (9.8–14.6)
Gender 8
6
10
Female
10
11
9
Orthopedics General surgery
3 5
2 6
2 5
Urology
0
1
0
Thoracic
3
0
4
Neurological
7
8
7
Vascular
0
0
1
174 (144–315)
245 (143–439)
215 (139–384)
Type of surgery
0.65
Type of post-surgical analgesia IV PCA opioids
0.55 0.53
Male
Surgical duration (min)
P value
0.65 0.38
7
9
7
IV opioids
4
4
6
Epidural
4
4
2
Non-opioid analgesics
3
0
4
123
Pediatr Surg Int
Fig. 2 Box plots demonstrating greater reduction in pain burden in the audio therapy patients compared to control. Data were analyzed using the Mann–Whitney U test (P \ 0.05). Min 9 pain score = minutes multiplied by pain scores (0–10 scale). The limits of the box plots denote 25 and 75 % quartiles. Dots outside whiskers represent outliers
median (IQR) for the time to the second treatment was 23 (21.5–25.7), 24 (20–42.2) and 22.7 (19.7–24.5) h for the music, audiobook and control, respectively, P = 0.56. Pain burden was reduced in the music and audiobook groups compared to control, median (IQR) of -60 (-90 to 0), -45 (-90 to 0) and 0 (-30 to 90) (60 min 9 pain score), respectively, P = 0.04. A pairwise comparison between the music and the control group did not achieve statistical significance after correcting for multiple comparisons (P = 0.055). We found that two patients in the audiobook, four in the music and three in control group received analgesic medications during the intervention, which demonstrated a balanced effect of potential confounders (P = 0.9). An exploratory analysis of audio therapy (music or audiobooks) compared to control group demonstrated a reduced pain burden in the audio therapy group compared to control, median (IQR) of -60 (-90 to 0) and 0 (-30 to 90), respectively, P = 0.01 (Fig. 2). A generalized linear regression analysis demonstrated an independent group effect on pain reduction even after adjusting for the mean pain scores recorded at the beginning of the treatment, slope of regression line -56.8 ± 24 goodness of fit r2 = 0.25 and slope significantly different from 0 (P = 0.02).
Discussion The most important finding of the current investigation was the reduction in post-surgical pain in children exposed to music or audiobooks compared to control after major surgery. The reduction in pain burden was one point (0–10
123
scale) over 1 h of total treatment that the audio therapy groups received compared to control. Our results suggest that audio therapy should be available to minimize postsurgical pain in children undergoing major surgeries. Our findings are clinically important because audio therapy is not currently implemented to reduce post-surgical pain in children undergoing major surgeries. In addition, practice guidelines for post-surgical pain control in children do not recommend the use of audio therapy as a method of analgesia control in children. To the best of our knowledge, this is the first randomized study to evaluate and demonstrate the use of patient-preferred audio therapy as promising non-pharmacological strategy to control postsurgical pain in children. Another important finding of the current investigation was the detection of an effect in the audio therapy groups to minimize post-surgical pain irrespective of the baseline pain score. This fact suggests that audio therapy may not only be effective as an adjunct for major surgeries but also to less painful procedures performed in the ambulatory setting [16, 17]. Ambulatory patients cannot rely on potent and rapid acting intravenous drugs to minimize pain [18]. After children are discharged home from the ambulatory surgical unit, parents can continue to use audio therapy to reduce post-surgical pain. We did not detect a difference in the analgesic effect of music compared to audiobooks in the current study. It is possible that the distracting and anxiety relieving effect of an audio therapy may be responsible for the reduction in post-surgical pain regardless of the audio method utilized. Children can likely chose between the two methods according to their preference without significant detriment in the post-surgical pain control. Since anxiety and pain are often related, future studies to examine the efficacy of audio therapy on post-surgical pain should also include an anxiety assessment [19]. In contrast to opioid analgesics, the lack of side effects of audio therapy seems to pave a promising pathway for the implementation of this intervention for children undergoing major surgeries. We believe that costs associated with the audio intervention should not be considered a major barrier to implement the audio interventions to minimize pain in children undergoing major surgery. Improvement in analgesic control after surgery has been associated with improvements in important economic outcomes in the adult population such as reduction of hospital length of stay or unanticipated hospital readmission after surgery [20, 21]. We observed beneficial effects of audio therapy even in some patients who received epidural analgesia. It is possible that the pain reduction effect of audio therapy in those patients was mediated by a reduction in post-surgical anxiety [22, 23]. Unfortunately, we did not concomitantly measured anxiety as part of our study outcomes. Future
Pediatr Surg Int
studies evaluating the effect of audio therapy on acute postsurgical pain should include a validated anxiety measurement as one of their outcomes. Our study should only be interpreted in the context of its limitations. We did not control for parent personality characteristics that could have affected children’s pain and anxiety [24]. However; since subjects were randomized, we expected that those differences would be evenly distributed among the study groups. Due to the nature of our intervention, we were not able to blind patients and observers. Lastly, we did not include children younger than 6 years of age and our findings of the current study remain to be extended to that age group. In summary, we demonstrated for the first time that audio therapy is an efficacious adjunct method to decrease post-surgical pain in children undergoing major surgeries. The type of audio therapy (music or audiobooks) does not seem to lead to significant clinical reduction in post-surgical pain. Due to the lack of side effects, audio therapy should be considered by hospitals and clinical practitioners as an important strategy to minimize pain in children undergoing major surgery. Acknowledgments The authors would like to thank Music Theory and Cognition Professor Richard Ashley, Northwestern University, Evanston, Illinois for his support of the study. Ann & Robert H. Lurie Children’s Hospital of Chicago; Northwestern University. Conflict of interest
None.
9.
10.
11.
12.
13.
14.
15. 16.
17.
References 18. 1. Jitpakdee T, Mandee S (2014) Strategies for preventing side effects of systemic opioid in postoperative pediatric patients. Paediatr Anaesth 24:561–568 2. Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA (2013) The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg 117:1401–1407 3. Niesters M, Overdyk F, Smith T, Aarts L, Dahan A (2013) Opioid-induced respiratory depression in paediatrics: a review of case reports. Br J Anaesth 110:175–182 4. Monitto CL, Kost-Byerly S, White E, Lee CK, Rudek MA, Thompson C, Yaster M (2011) The optimal dose of prophylactic intravenous naloxone in ameliorating opioid-induced side effects in children receiving intravenous patient-controlled analgesia morphine for moderate to severe pain: a dose finding study. Anesth Analg 113:834–842 5. Patino M, Sadhasivam S, Mahmoud M (2013) Obstructive sleep apnoea in children: perioperative considerations. Br J Anaesth 111:83–95 6. Dotta A, Braguglia A, Salvatori G (2011) Pharmacological research in neonatology. J Matern Fetal Neonatal Med 24:44–46 7. Rieder MJ, Carleton B (2014) Pharmacogenomics and adverse drug reactions in children. Front Genet 5:78 8. McNair C, Campbell Yeo M, Johnston C, Taddio A (2013) Nonpharmacological management of pain during common needle
19.
20.
21.
22.
23.
24.
puncture procedures in infants: current research evidence and practical considerations. Clin Perinatol 40:493–508 Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L (2008) Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr 8:117–128 Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S (2013) Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr 167:826–835 Caprilli S, Anastasi F, Grotto RP, Scollo Abeti M, Messeri A (2007) Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. J Dev Behav Pediatr 28:399–403 Robb SL, Burns DS, Stegenga KA, Haut PR, Monahan PO, Meza J, Stump TE, Cherven BO, Docherty SL, Hendricks-Ferguson VL, Kintner EK, Haight AE, Wall DA, Haase JE (2014) Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children’s Oncology Group. Cancer 120:909–917 Lee GY, Yamada J, Kyololo O, Shorkey A, Stevens B (2014) Pediatric clinical practice guidelines for acute procedural pain: a systematic review. Pediatrics 133:500–515 De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ (2012) Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg 115:262–267 Dexter F (2013) Wilcoxon–Mann–Whitney test used for data that are not normally distributed. Anesth Analg 117:537–538 Gurnaney H, Kraemer FW, Maxwell L, Muhly WT, Schleelein L, Ganesh A (2014) Ambulatory continuous peripheral nerve blocks in children and adolescents: a longitudinal 8-year single center study. Anesth Analg 118:621–627 Vons KM, Bijker JB, Verwijs EW, Majoor MH, de Graaff JC (2014) Postoperative pain during the first week after adenoidectomy and guillotine adenotonsillectomy in children. Paediatr Anaesth 24:476–482 Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ (2014) Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth 24:239–248 Lee MC, Tracey I (2013) Imaging pain: a potent means for investigating pain mechanisms in patients. Br J Anaesth 111:64–72 Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ, Enhanced Recovery Study Group (2014) Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg 118:1052–1061 Fawcett WJ, Mythen MG, Scott MJ (2012) Enhanced recovery: more than just reducing length of stay? Br J Anaesth 109:671–674 Lee MC, Tracey I (2013) Imaging pain: a potent means for investigating pain mechanisms in patients. Br J Anaesth 111:64–72 Carvalho B, Zheng M, Aiono-Le Tagaloa L (2014) A prospective observational study evaluating the ability of prelabor psychological tests to predict labor pain, epidural analgesic consumption, and maternal satisfaction. Anesth Analg 119:632–640 Esteve R, Marquina-Aponte V, Ramı´rez-Maestre C (2014) Postoperative pain in children: association between anxiety sensitivity, pain catastrophizing, and female caregivers’ responses to children’s pain. J Pain 15:157–168
123
ORIGINAL ARTICLE
The effect of audio therapy to treat postoperative pain in children undergoing major surgery: a randomized controlled trial B. S. Sunitha Suresh • Gildasio S. De Oliveira Jr. Santhanam Suresh
•
Accepted: 3 December 2014 Ó Springer-Verlag Berlin Heidelberg 2015
Abstract Purpose To evaluate the analgesic effect of music and audiobooks in children undergoing major surgical procedures when compared to a control (silence) group. Methods The study was a prospective and randomized trial. Children undergoing major surgeries were randomized to one of the three groups: music, audiobook or control (silence). The primary outcome was the pain burden reduction by two treatments within 48 h postoperatively. Pain burden was measured using the area under the pain scale versus the 30 min interval for each treatment. Results 60 patients were recruited and 56 completed the study. Pain burden was reduced in the music and audiobook groups compared to control, median (IQR) of -60 (-90 to 0), -45 (-90 to 0) and 0 (-30 to 90) (min 9 pain score), respectively, P = 0.04. A linear regression analysis demonstrated an independent group effect on pain reduction even after adjusting for the mean pain scores recorded at the beginning of the treatment, slope of regression line -56.8 ± 24 goodness of fit r2 = 0.25 and slope significantly different from 0 (P = 0.02). Conclusions Audio therapy is an efficacious adjunct method to decrease post-surgical pain in children
B. S. Sunitha Suresh G. S. De Oliveira Jr. S. Suresh Department of Pediatric Anesthesiology, Ann & Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL, USA Present Address: B. S. Sunitha Suresh Johns Hopkins Medical School, Baltimore, MD, USA G. S. De Oliveira Jr. (&) Department of Anesthesiology, Northwestern University, 241 East Huron St F5-704, Chicago, IL, USA e-mail: [email protected]
undergoing major surgeries. Audio therapy should be considered as an important strategy to minimize pain in children undergoing major surgery. Keywords Music post-surgical pain Music treatment pain surgery children
Introduction The treatment of post-surgical pain in children often relies on the use of opioid analgesics [1, 2]. Due to the fear of opioid-related side effects such as respiratory depression, caregivers usually limit the amount of opioids given to children and this practice frequently results in poor postsurgical analgesic control [3–5]. In addition, the use of non-opioid drugs for pain control in children is commonly hindered by the lack of studies addressing efficacy and safety of those drugs in this patient population [6, 7]. The use of non-pharmacological therapies such as music has been evaluated with promising results to minimize pain in children [8]. Nevertheless, prior studies focused primarily in the use of music therapy to minimize pain associated with short medical procedures such as venipuncture but not for the treatment of post-surgical pain [9–11]. The distracting and anxiolytic properties of audiobooks may also have a promising effect on pain control in children undergoing surgery but their efficacy remains to be evaluated [12]. Currently, there is a lack of recommendation for non-pharmacological strategies by practice guidelines for the treatment of post-surgical pain in children [13]. The main objective of the current investigation was to evaluate the potential analgesic effect of music and audiobooks in children undergoing major surgical procedures
123
Pediatr Surg Int
when compared to a control (silence) group. We hypothesized that children exposed to music or audiobooks during the post-surgical period would have less pain than children in the control group.
Materials and methods This was a prospective, randomized and controlled study. The study was approved by the Ann & Robert H. Lurie Children’s Hospital’s Institutional Review Board. Written informed consent was obtained from the guardians of all patients and assent was also obtained from children older than 8 years of age. Children aged from 6 to 18 years scheduled for major elective orthopedic, neurosurgical, urological, plastic or general surgeries at Lurie Children’s Hospital of Chicago, USA were recruited to participate in this study. Children were excluded if they were hearing impaired, mentally challenged and if they had chronic pain or opioids use. Patients were randomized using a computer-generated table of random numbers to three groups: a music, an audiobook and a silence control group. Allocation was concealed by keeping the allocated treatment group in a sealed opaque envelope that was opened only after the child entered the study. Prior to surgery, if the patients were allocated to the music or the audiobook group, they were provided a playlist for music and a set of audiobooks to choose from. This allowed them to make their choice prior to any effects of anesthesia or surgery. The Audiobook group wore noise-canceling headphones (Etymotics; Elk Grove Village, IL, USA) connected to an iPodTM (Apple Incorporated; Cupertino, CA, USA) containing a selection of audiobooks and listened to an audiobook of their choice for 30 min. For the Music Group, a playlist from selections provided on an iPodTM was created. Children wore noisecanceling headphones and listened to their music for 30 min. The Silence control group received no intervention. The Faces Pain Scale-Revised FPS-R, a validated scale to assess pain in children of 4 or 5 years old, was used to evaluate pain. Pain scores were assessed before treatment and 30 min after treatment within 48 h after surgery. The difference between post and pre-treatment pain scores was calculated as the main treatment effect for the study. This method accounted for differences in pain intensity among distinct surgeries and differences in analgesic treatments. The primary outcome was the pain burden reduction by the two treatments. Pain burden reduction was measured by the decrement in the area under the pain scale versus the 30 min time curve for each treatment using the trapezoidal method (Graph Pad Prism version 5.03, Graph Pad Software, Inc., La Jolla, Ca) [14]. For all children, pain was
123
treated according to the standard of the institution and adapted to the specific type of surgery and age. Other data collected included age, gender, surgical type and duration of surgery. All data were collected by a single investigator (SS). In a one-way ANOVA study, sample sizes of 18, 18 and 18 will be obtained from the three groups whose means are to be compared. The total sample size of 54 subjects achieves 82 % power to detect differences with an effect size of 1 point difference in pain scores between groups and using a F test with a 0.01 significance level. The size of variation in the means is represented by their standard deviation which is 0.82. The common standard deviation within a group is assumed to be 1.5. 20 patients per group were recruited to account for possible drop outs. Power calculation was performed using PASS version 8.0.15, 2010 (NCSS, LLC, Kaysville, UT). The Shapiro–Wilk and Kolmogorov–Smirnov tests were used to test the hypothesis of normal distribution. Normally, distributed interval data are reported as mean (SD) and were evaluated by one-way ANOVA. Non-normally distributed interval data and ordinal data are reported as median [interquartile range (IRQ)] using the Kruskal– Wallis H test. Post-hoc comparisons were made using the Tukey–Kramer or Dunn’s test with Bonferroni correction for multiple comparisons [15]. Categorical variables were evaluated using the Fisher’s exact test. An additional exploratory analysis was performed by combing the audiobook and music groups (audio therapy) and median differences and 95 % confidence intervals of the differences in pain burden reduction were calculated using a 10,000 sample bootstrapping method. All reported P values are two tailed. A generalized linear regression model was also conducted to control for the treatment effect across different initial pain scores. Statistical analysis was performed using Stata version 12 (StataCorporation 2011. Stata Statistical Software: Release 12; College Station, TX: StataCorp LP.)
Results Sixty children undergoing major surgery were recruited to the study between July 2010 and December 2010. The details of the conduct of the study are presented in Fig. 1. Six patients were excluded from the final analysis. Three patients were discharged home before receiving the two interventions and three patients requested to be excluded from the study. There were no differences on baseline characteristics among the study groups (Table 1). The median (IQR) for time to the first treatment was 18.7 (17.5–20.2), 17.2 (16–23) and 18.1 (16–21.7) h for the music, audiobook and control, respectively, P = 0.96. The
Pediatr Surg Int Fig. 1 Consort flow diagram for the study
Table 1 Baseline characteristics of the study groups
Age (years)
Music (n = 18)
Audiobook (n = 17)
Control (n = 19)
10.9 (9.1–13.9)
12.9 (11.5–13.9)
12.4 (9.8–14.6)
Gender 8
6
10
Female
10
11
9
Orthopedics General surgery
3 5
2 6
2 5
Urology
0
1
0
Thoracic
3
0
4
Neurological
7
8
7
Vascular
0
0
1
174 (144–315)
245 (143–439)
215 (139–384)
Type of surgery
0.65
Type of post-surgical analgesia IV PCA opioids
0.55 0.53
Male
Surgical duration (min)
P value
0.65 0.38
7
9
7
IV opioids
4
4
6
Epidural
4
4
2
Non-opioid analgesics
3
0
4
123
Pediatr Surg Int
Fig. 2 Box plots demonstrating greater reduction in pain burden in the audio therapy patients compared to control. Data were analyzed using the Mann–Whitney U test (P \ 0.05). Min 9 pain score = minutes multiplied by pain scores (0–10 scale). The limits of the box plots denote 25 and 75 % quartiles. Dots outside whiskers represent outliers
median (IQR) for the time to the second treatment was 23 (21.5–25.7), 24 (20–42.2) and 22.7 (19.7–24.5) h for the music, audiobook and control, respectively, P = 0.56. Pain burden was reduced in the music and audiobook groups compared to control, median (IQR) of -60 (-90 to 0), -45 (-90 to 0) and 0 (-30 to 90) (60 min 9 pain score), respectively, P = 0.04. A pairwise comparison between the music and the control group did not achieve statistical significance after correcting for multiple comparisons (P = 0.055). We found that two patients in the audiobook, four in the music and three in control group received analgesic medications during the intervention, which demonstrated a balanced effect of potential confounders (P = 0.9). An exploratory analysis of audio therapy (music or audiobooks) compared to control group demonstrated a reduced pain burden in the audio therapy group compared to control, median (IQR) of -60 (-90 to 0) and 0 (-30 to 90), respectively, P = 0.01 (Fig. 2). A generalized linear regression analysis demonstrated an independent group effect on pain reduction even after adjusting for the mean pain scores recorded at the beginning of the treatment, slope of regression line -56.8 ± 24 goodness of fit r2 = 0.25 and slope significantly different from 0 (P = 0.02).
Discussion The most important finding of the current investigation was the reduction in post-surgical pain in children exposed to music or audiobooks compared to control after major surgery. The reduction in pain burden was one point (0–10
123
scale) over 1 h of total treatment that the audio therapy groups received compared to control. Our results suggest that audio therapy should be available to minimize postsurgical pain in children undergoing major surgeries. Our findings are clinically important because audio therapy is not currently implemented to reduce post-surgical pain in children undergoing major surgeries. In addition, practice guidelines for post-surgical pain control in children do not recommend the use of audio therapy as a method of analgesia control in children. To the best of our knowledge, this is the first randomized study to evaluate and demonstrate the use of patient-preferred audio therapy as promising non-pharmacological strategy to control postsurgical pain in children. Another important finding of the current investigation was the detection of an effect in the audio therapy groups to minimize post-surgical pain irrespective of the baseline pain score. This fact suggests that audio therapy may not only be effective as an adjunct for major surgeries but also to less painful procedures performed in the ambulatory setting [16, 17]. Ambulatory patients cannot rely on potent and rapid acting intravenous drugs to minimize pain [18]. After children are discharged home from the ambulatory surgical unit, parents can continue to use audio therapy to reduce post-surgical pain. We did not detect a difference in the analgesic effect of music compared to audiobooks in the current study. It is possible that the distracting and anxiety relieving effect of an audio therapy may be responsible for the reduction in post-surgical pain regardless of the audio method utilized. Children can likely chose between the two methods according to their preference without significant detriment in the post-surgical pain control. Since anxiety and pain are often related, future studies to examine the efficacy of audio therapy on post-surgical pain should also include an anxiety assessment [19]. In contrast to opioid analgesics, the lack of side effects of audio therapy seems to pave a promising pathway for the implementation of this intervention for children undergoing major surgeries. We believe that costs associated with the audio intervention should not be considered a major barrier to implement the audio interventions to minimize pain in children undergoing major surgery. Improvement in analgesic control after surgery has been associated with improvements in important economic outcomes in the adult population such as reduction of hospital length of stay or unanticipated hospital readmission after surgery [20, 21]. We observed beneficial effects of audio therapy even in some patients who received epidural analgesia. It is possible that the pain reduction effect of audio therapy in those patients was mediated by a reduction in post-surgical anxiety [22, 23]. Unfortunately, we did not concomitantly measured anxiety as part of our study outcomes. Future
Pediatr Surg Int
studies evaluating the effect of audio therapy on acute postsurgical pain should include a validated anxiety measurement as one of their outcomes. Our study should only be interpreted in the context of its limitations. We did not control for parent personality characteristics that could have affected children’s pain and anxiety [24]. However; since subjects were randomized, we expected that those differences would be evenly distributed among the study groups. Due to the nature of our intervention, we were not able to blind patients and observers. Lastly, we did not include children younger than 6 years of age and our findings of the current study remain to be extended to that age group. In summary, we demonstrated for the first time that audio therapy is an efficacious adjunct method to decrease post-surgical pain in children undergoing major surgeries. The type of audio therapy (music or audiobooks) does not seem to lead to significant clinical reduction in post-surgical pain. Due to the lack of side effects, audio therapy should be considered by hospitals and clinical practitioners as an important strategy to minimize pain in children undergoing major surgery. Acknowledgments The authors would like to thank Music Theory and Cognition Professor Richard Ashley, Northwestern University, Evanston, Illinois for his support of the study. Ann & Robert H. Lurie Children’s Hospital of Chicago; Northwestern University. Conflict of interest
None.
9.
10.
11.
12.
13.
14.
15. 16.
17.
References 18. 1. Jitpakdee T, Mandee S (2014) Strategies for preventing side effects of systemic opioid in postoperative pediatric patients. Paediatr Anaesth 24:561–568 2. Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA (2013) The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg 117:1401–1407 3. Niesters M, Overdyk F, Smith T, Aarts L, Dahan A (2013) Opioid-induced respiratory depression in paediatrics: a review of case reports. Br J Anaesth 110:175–182 4. Monitto CL, Kost-Byerly S, White E, Lee CK, Rudek MA, Thompson C, Yaster M (2011) The optimal dose of prophylactic intravenous naloxone in ameliorating opioid-induced side effects in children receiving intravenous patient-controlled analgesia morphine for moderate to severe pain: a dose finding study. Anesth Analg 113:834–842 5. Patino M, Sadhasivam S, Mahmoud M (2013) Obstructive sleep apnoea in children: perioperative considerations. Br J Anaesth 111:83–95 6. Dotta A, Braguglia A, Salvatori G (2011) Pharmacological research in neonatology. J Matern Fetal Neonatal Med 24:44–46 7. Rieder MJ, Carleton B (2014) Pharmacogenomics and adverse drug reactions in children. Front Genet 5:78 8. McNair C, Campbell Yeo M, Johnston C, Taddio A (2013) Nonpharmacological management of pain during common needle
19.
20.
21.
22.
23.
24.
puncture procedures in infants: current research evidence and practical considerations. Clin Perinatol 40:493–508 Klassen JA, Liang Y, Tjosvold L, Klassen TP, Hartling L (2008) Music for pain and anxiety in children undergoing medical procedures: a systematic review of randomized controlled trials. Ambul Pediatr 8:117–128 Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S (2013) Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr 167:826–835 Caprilli S, Anastasi F, Grotto RP, Scollo Abeti M, Messeri A (2007) Interactive music as a treatment for pain and stress in children during venipuncture: a randomized prospective study. J Dev Behav Pediatr 28:399–403 Robb SL, Burns DS, Stegenga KA, Haut PR, Monahan PO, Meza J, Stump TE, Cherven BO, Docherty SL, Hendricks-Ferguson VL, Kintner EK, Haight AE, Wall DA, Haase JE (2014) Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children’s Oncology Group. Cancer 120:909–917 Lee GY, Yamada J, Kyololo O, Shorkey A, Stevens B (2014) Pediatric clinical practice guidelines for acute procedural pain: a systematic review. Pediatrics 133:500–515 De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ (2012) Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg 115:262–267 Dexter F (2013) Wilcoxon–Mann–Whitney test used for data that are not normally distributed. Anesth Analg 117:537–538 Gurnaney H, Kraemer FW, Maxwell L, Muhly WT, Schleelein L, Ganesh A (2014) Ambulatory continuous peripheral nerve blocks in children and adolescents: a longitudinal 8-year single center study. Anesth Analg 118:621–627 Vons KM, Bijker JB, Verwijs EW, Majoor MH, de Graaff JC (2014) Postoperative pain during the first week after adenoidectomy and guillotine adenotonsillectomy in children. Paediatr Anaesth 24:476–482 Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ (2014) Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth 24:239–248 Lee MC, Tracey I (2013) Imaging pain: a potent means for investigating pain mechanisms in patients. Br J Anaesth 111:64–72 Miller TE, Thacker JK, White WD, Mantyh C, Migaly J, Jin J, Roche AM, Eisenstein EL, Edwards R, Anstrom KJ, Moon RE, Gan TJ, Enhanced Recovery Study Group (2014) Reduced length of hospital stay in colorectal surgery after implementation of an enhanced recovery protocol. Anesth Analg 118:1052–1061 Fawcett WJ, Mythen MG, Scott MJ (2012) Enhanced recovery: more than just reducing length of stay? Br J Anaesth 109:671–674 Lee MC, Tracey I (2013) Imaging pain: a potent means for investigating pain mechanisms in patients. Br J Anaesth 111:64–72 Carvalho B, Zheng M, Aiono-Le Tagaloa L (2014) A prospective observational study evaluating the ability of prelabor psychological tests to predict labor pain, epidural analgesic consumption, and maternal satisfaction. Anesth Analg 119:632–640 Esteve R, Marquina-Aponte V, Ramı´rez-Maestre C (2014) Postoperative pain in children: association between anxiety sensitivity, pain catastrophizing, and female caregivers’ responses to children’s pain. J Pain 15:157–168
123
