Pediatric Anesthesia ISSN 1155-5645
ORIGINAL ARTICLE
Acupuncture for posttonsillectomy pain in children: a randomized, controlled study Peter Gilbey1,2, Shlomi Bretler1, Yaniv Avraham3, Adi Sharabi-Nov4, Sasha Ibrgimov5 & Anthony Luder2,5 1 2 3 4 5
Otolaryngology, Head and Neck Surgery Unit, Ziv Medical Center, Safed, Israel Faculty of Medicine in the Galilee, Bar-Ilan University, Safed, Israel College of Complimentary Medicine, Or Haganuz, Israel Research Wing, Ziv Medical Center, Safed, Israel Department of Pediatrics, Ziv Medical Center, Safed, Israel
What is already known
• Previous studies have shown that acupuncture is effective for the treatment of postoperative pain and, with nonsteroidal anti-inflammatory drugs (NSAID) use, is effective in adults for the treatment of pain after tonsillectomy. Acupuncture has been shown to be safe in children.
What this article adds
• This is the first study that has demonstrated the positive effect of acupuncture on posttonsillectomy pain in children.
Implications for translation
• Acupuncture has the potential to be an effective additional treatment to standard analgesic treatment for post-
tonsillectomy pain in children. Acupuncture may decrease consumption of pain medication and increase parental satisfaction with postoperative pain control.
Keywords tonsillectomy; children; postoperative pain; acupuncture; complementary medicine; Chinese medicine Correspondence Dr P. Gilbey, Otolaryngology, Head and Neck Surgery Unit, Ziv Medical Center, Rambam St, Safed 13100, Israel Email: [email protected] Section Editor: Joseph Cravero Accepted 22 December 2014 doi:10.1111/pan.12621 Clinical Trial Registration: NCT01285687
© 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 603–609
Summary Background: Surgeons have searched for the technique or medication that will produce a ‘painless tonsillectomy’; however, this seems to be an impossible goal. Previous studies have shown that perioperative acupuncture may be a useful adjunct for acute postoperative pain and that acupuncture, in addition to nonsteroidal anti-inflammatory drugs, is effective in adults for the treatment of postoperative swallowing pain after tonsillectomy. Acupuncture has been shown to be safe in children. A retrospective review of acupuncture for posttonsillectomy pain in juvenile patients showed a significantly reduced pain score immediately after treatment. Aim: To examine whether acupuncture, in addition to conventional analgesic treatment, will be effective in the treatment of posttonsillectomy pain in children. Methods: We conducted a randomized, controlled, single-blinded study comparing conventional postoperative analgesic treatment with the same regime plus acupuncture to assess whether postoperative treatment of children aged 3–12 years undergoing tonsillectomy with acupuncture will reduce pain and to examine possible unwanted effects of this treatment. Results: Sixty children were recruited and randomly divided into a study group and a control group. The results indicate that in the study group, there 603
P. Gilbey et al.
Acupuncture for posttonsillectomy pain in children
was less pain, less analgesic drug consumption, and higher patient/parent satisfaction with analgesic treatment scores. No adverse effects were recorded. Conclusions: Acupuncture, in addition to conventional analgesic treatment, is an effective treatment for posttonsillectomy pain. Acupuncture is safe and well received by children and their parents.
Introduction Tonsillectomy is one of the commonest surgical procedures performed throughout the world. Despite this, there remains significant morbidity associated with the recovery period. Postoperative pain is distressing for the patient and the family, and pain-related poor oral intake can lead to dehydration and inflammation. These complications may be severe enough to require re-hospitalization (1). Doctors have searched for a technique or medication that will produce a ‘painless tonsillectomy’ (2). Studies have looked at preoperative medications, pre- or posttonsillectomy injection of local anesthetics (3), variations in techniques used to remove the tonsils (4), intra-operative medications, partial vs total tonsillectomy (5), and postoperative pain control with acetaminophen/paracetamol, opioids, and nonsteroidal anti-inflammatory drugs (NSAIDS). There is no agreement on any particular medication, technique, or tool to achieve this seemingly impossible goal (5). Two recent systematic reviews of randomized clinical trials evaluating clinical evidence of the efficacy of acupuncture for postoperative pain control have been conducted. One concluded that the evidence for efficacy is suggestive but not definitive (6). The other concluded that perioperative acupuncture may be a useful adjunct for acute postoperative pain (7). Sertel et al. (8) conducted a randomized, prospective study in adult patients evaluating the efficacy of acupuncture for painful dysphagia after tonsillectomy. The authors showed reduction in postoperative tonsillectomy pain without unwanted effects. The use of acupuncture in children is more complex than in adults. A potential difficulty is children’s fear of needles (9). Although a great deal of research has been conducted on the safety and efficacy of acupuncture in adults, acupuncture in the pediatric population has received less attention. A recent paper reviewed the evidence base for the safety and efficacy of acupuncture in pediatrics (10). Nine randomized controlled clinical trials that detailed the occurrence of adverse events in children, if any, were included. The incidence of side effects was estimated to be 1.55/100 treatments. Puncture redness was the most commonly reported unwanted effect. The risk of serious adverse events was 5.36/10 000 treatments. The National Institutes of Health Consensus Statement (11) states that 604
one of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted procedures for the same conditions. Shenkman et al. (12) evaluated acupressure–acupuncture antiemetic prophylaxis in children undergoing tonsillectomy. Redness occurred in 8.5% of acupuncture sites. Ochi (13) conducted a retrospective review of 31 juvenile patients receiving acupuncture for posttonsillectomy pain. This report showed a significantly reduced pain score immediately after treatment. However, the treatment was initiated up to 10 days after surgery, and the study sample was a sample of convenience, employing neither random assignment nor control conditions against which to compare the acupuncture treatment. Both the researcher and the patients were motivated to see pain reduced. To our knowledge, acupuncture has not yet been evaluated by a randomized controlled study as treatment for posttonsillectomy pain in children. The objective of this study was to assess whether in-hospital postoperative treatment of children undergoing tonsillectomy with acupuncture reduces pain, and to examine possible unwanted effects of this treatment. We hypothesized that acupuncture, in addition to conventional analgesic treatment, would be effective in the treatment of posttonsillectomy pain in children and would be well received by children and their parents. Methods A randomized, controlled, single-blinded study comparing conventional postoperative analgesia consisting of paracetamol-on-demand with the same regime plus acupuncture was performed. The study is in accordance with the ethical standards of the Helsinki Declaration and was approved by the Human Experimentation Ethics Committee of the Ziv Medical Center and the Israeli Ministry of Health. Patients were recruited through the preoperative clinic conducted on the day before surgery. All parents and children were recruited for the study before randomization, and given a full explanation of the study by an experienced member of the research team. Written informed consent was obtained before randomization from the parents or guardians of the children who served as subjects of the investigation. Children aged 3–12 years undergoing tonsillectomy, with or © 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 603–609
P. Gilbey et al.
without adenoidectomy, were included in the study. Indications for surgery included tonsillar hypertrophy with sleep disordered breathing and/or recurrent tonsillar infections. Exclusion criteria were lack of parental consent, skin lesions near acupuncture sites, psychiatric disorders, coagulopathy, drug allergies to regular analgesic treatment, intake of medications possibly affecting postoperative pain, and previous acupuncture treatment of the child or his/her immediate family. Patients were randomized into two treatment groups. The randomization was performed by allocating the first patient to register at the clinic to the study group, the second to the control group, the third to the study group, and so on. The patients were booked into the clinic by the secretariat without the knowledge of the study team, and the order of registration to the clinic was unaffected by any potential confounding factor. Both groups underwent tonsillectomy using sharp and blunt cold dissection. This pilot study was limited by budget, but to ensure correct use of parametric statistical tests, both the acupuncture treatment group and the control group included 30 participants. Hemostasis was achieved by local pressure and by minimal, low-power, short-duration monopolar electrocautery if needed. If necessary, sutures were used to control bleeding. All patients received general anesthesia using standard and uniform anesthetic technique including routine perioperative administration of dexamethasone in accordance with the 2011 American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) practice guidelines (14). Intra-operative analgesia included i.v. fentanyl 2 lgkg 1 and i.v. paracetamol 15 mgkg 1. Initial postoperative pain control included i.v. pethidine 0.1 mgkg 1 in postanesthetic recovery unit. All the patients received oral analgesic treatment according to a standard protocol in the pediatrics department (described below). The acupuncture group received, in addition, acupuncture according to accepted Chinese medical techniques. All acupuncture treatments were performed by the same member of the research team (YA) who has wide experience in performing pediatric acupuncture, using the same type of needles, the same points, and the same depth of penetration. Sterile, disposable, FDA-approved acupuncture needles (0.20 * 15 mm; Dong Bang Acupuncture Inc., Chungnam, Korea) were used. Acupuncture was performed bilaterally on each patient. Altogether six needles were used. The needles penetrated the skin to a depth of 5– 10 mm and were kept in place for no more than 5 min. The acupuncture points used were: LI 4 (Hand), LI 11 (Elbow), and St 44 (Foot), according to Chinese acupuncture mapping (15–17). Treatment was repeated three times during the hospital stay. The first treatment © 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 603–609
Acupuncture for posttonsillectomy pain in children
was given approximately 2 h after discharge from the postoperative unit. The second treatment was given on the same evening, approximately 4–8 h after the first treatment, and the third treatment was given the following morning, approximately 12–18 h after the second treatment. Exact treatment times were recorded in the patient’s file. All treatments were performed in a designated room outside the pediatric ward. Children in the control group were also removed from the pediatric ward at treatment times and were interviewed about their postoperative recovery. These interviews were conducted in the same designated room under the same conditions as the acupuncture group. According to standard operating procedure in the pediatric department, every child was treated with oral paracetamol using a standard dosage regime of 10 mgkg 1 per dose (18) by request every 4–6 h and not more than five doses in 24 h, and not continuously for more than 3 days postoperatively. Oral analgesia by request and not at regular intervals is the accepted postoperative analgesic treatment protocol in our institute. In addition, oral ibuprofen 10 mgkg 1 per dose was given on request only, no more than three doses in 24 h, in cases in which oral paracetamol was not sufficient for pain control. The primary outcome was postoperative pain. Pain was assessed using the Wong–Baker faces visual analog pain scale which is a widely used and validated measure of postoperative pain in children (19,20). Pain assessment was done by experienced nursing staff who were not connected to the study and who were unaware of the child’s randomization status. Nurses, parents, and children were repeatedly instructed not to discuss the randomization status of the children. No redness at acupuncture sites was noted, and this could therefore not identify children as belonging to the acupuncture group. Pain scores were recorded in both groups upon arrival at the pediatrics department, upon request of analgesics, and regularly every 4 h until discharge unless the child was asleep. Pain scores were also recorded in both groups immediately before acupuncture treatment times and 1 h after acupuncture treatment times. In addition, parents were asked to score, on a five-point scale (1 = not at all satisfied, 5 = extremely satisfied), their general satisfaction with the postoperative analgesic treatment. Acupuncture treatments took place at least 1 h after intake of oral analgesics to minimize overlapping effects. All children were assessed for side effects of acupuncture by a pediatrician. Specifically, these side effects included pain, tenderness, redness, swelling, or any other unusual skin or soft tissue reaction at the acupuncture points. This study focused on postoperative pain during the first 24 h following surgery, and no evaluation of pain during the following days was performed. 605
P. Gilbey et al.
Acupuncture for posttonsillectomy pain in children
Statistical methods Descriptive Statistics: For categorical variables, summary tables are provided giving sample size, absolute, and relative frequencies. For continuous variables, summary tables are provided giving arithmetic mean (M) and standard deviation (SD). Pearson’s chi-squared or Fisher’s exact test is applied for testing the differences between the study groups for the categorical parameters. The two-sample t-test is applied for testing differences between the study groups for quantitative parameters. All tests applied are two-tailed, and P value of 5% or less is considered statistically significant. The data were analyzed using the SPSS version 20.0.0.2 (SPSS Inc., Chicago, IL, USA). Results Eighty-eight children underwent tonsillectomy at the Ziv Medical Center during the study period. Of these, 28 declined to participate in the study. Sixty children were recruited to the study, and were randomized into two groups: 30 in the acupuncture group and 30 in the control group. Demographic data, indication for surgery, type of surgery performed, and postoperative complications are presented in Table 1. The results of pain scores recorded in the two groups are presented in Figure 1. Compared to the control group, children who received acupuncture had significantly less pain following the second and third treatments (about 8 and 20 h postoperatively, respectively). In both groups, a biphasic pattern of postoperative pain was observed with a tendency to reduced pain 4 h after surgery, and a secondary rise at 8 h, before a final and sustained reduction in pain. However, in the acupuncture group, the reduction in pain following the first treatment (4 h) was substantial and therefore the pain scores preceding the second treatment Table 1 Demographic characteristics of study participants
Age (years)
Acupuncture group (n = 30)
Control group (n = 30)
M
SD
M
SD
5.1 N 17
2.2 % 57
6.1 N 17
2.6 % 57
23 77
8 22
26 73
20 3
5 2
17 7
57 77
22 22
73 73
Male Procedure performed Tonsillectomy 7 Adeno-tonsillectomy 23 Postoperative complications Vomiting 6 Bleeding 1 Indication for surgery Chronic tonsillitis 17 Hypertrophy 23
606
Figure 1 Pain scores (VAS) in both groups before and after treatment times. Arrows designate acupuncture treatment times. Note: a-b, A-B Different letters represent significant differences between groups (P ≤ 0.01).
at 8 h were lower in comparison to the pain scores preceding the first treatment. In contrast, in the control group, the pain scores preceding the second treatment at 8 h postoperatively were higher than the pain scores preceding the first treatment at 4 h postoperatively. Following completion of all the three treatments, the pain scores in the acupuncture group were significantly lower than the control group. The amounts of analgesic drug support required were lower in the acupuncture group in comparison to the control group (Table 2). The overall analgesic drug consumption and the paracetamol consumption were significantly lower, whereas the ibuprofen consumption was lower but not significantly so. Average overall patient/parent satisfaction with analgesic treatment scores were significantly higher in the acupuncture group than in the control group (Table 2). No children or parents elected to end their participation in the study after receiving the first or second acupuncture treatment. No adverse effects as a result of the acupuncture treatments were recorded. Discussion Posttonsillectomy pain represents a significant problem and is therefore of great clinical interest. In the first study to compare the analgesic efficacy of acupuncture to a nonspecific acupuncture control (sham acupuncture) and a nonacupuncture standard medica© 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 603–609
P. Gilbey et al.
Acupuncture for posttonsillectomy pain in children
Table 2 Analgesic medication consumption and parental satisfaction with pain control in both groups
Paracetamol (total number of doses administered) Ibuprofen (total number of doses administered) Paracetamol and ibuprofen (total number of doses administered) Parental satisfaction with postoperative analgesic treatment (1–5)
Acupuncture group
Control group
M
SD
M
SD
1.0 0.8 1.8
0.9 0.7 1.1
1.5 1.1 2.5
1.1 1.0 1.4
0.050 0.179 0.020
4.8
0.6
3.9
1.0
ORIGINAL ARTICLE
Acupuncture for posttonsillectomy pain in children: a randomized, controlled study Peter Gilbey1,2, Shlomi Bretler1, Yaniv Avraham3, Adi Sharabi-Nov4, Sasha Ibrgimov5 & Anthony Luder2,5 1 2 3 4 5
Otolaryngology, Head and Neck Surgery Unit, Ziv Medical Center, Safed, Israel Faculty of Medicine in the Galilee, Bar-Ilan University, Safed, Israel College of Complimentary Medicine, Or Haganuz, Israel Research Wing, Ziv Medical Center, Safed, Israel Department of Pediatrics, Ziv Medical Center, Safed, Israel
What is already known
• Previous studies have shown that acupuncture is effective for the treatment of postoperative pain and, with nonsteroidal anti-inflammatory drugs (NSAID) use, is effective in adults for the treatment of pain after tonsillectomy. Acupuncture has been shown to be safe in children.
What this article adds
• This is the first study that has demonstrated the positive effect of acupuncture on posttonsillectomy pain in children.
Implications for translation
• Acupuncture has the potential to be an effective additional treatment to standard analgesic treatment for post-
tonsillectomy pain in children. Acupuncture may decrease consumption of pain medication and increase parental satisfaction with postoperative pain control.
Keywords tonsillectomy; children; postoperative pain; acupuncture; complementary medicine; Chinese medicine Correspondence Dr P. Gilbey, Otolaryngology, Head and Neck Surgery Unit, Ziv Medical Center, Rambam St, Safed 13100, Israel Email: [email protected] Section Editor: Joseph Cravero Accepted 22 December 2014 doi:10.1111/pan.12621 Clinical Trial Registration: NCT01285687
© 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 603–609
Summary Background: Surgeons have searched for the technique or medication that will produce a ‘painless tonsillectomy’; however, this seems to be an impossible goal. Previous studies have shown that perioperative acupuncture may be a useful adjunct for acute postoperative pain and that acupuncture, in addition to nonsteroidal anti-inflammatory drugs, is effective in adults for the treatment of postoperative swallowing pain after tonsillectomy. Acupuncture has been shown to be safe in children. A retrospective review of acupuncture for posttonsillectomy pain in juvenile patients showed a significantly reduced pain score immediately after treatment. Aim: To examine whether acupuncture, in addition to conventional analgesic treatment, will be effective in the treatment of posttonsillectomy pain in children. Methods: We conducted a randomized, controlled, single-blinded study comparing conventional postoperative analgesic treatment with the same regime plus acupuncture to assess whether postoperative treatment of children aged 3–12 years undergoing tonsillectomy with acupuncture will reduce pain and to examine possible unwanted effects of this treatment. Results: Sixty children were recruited and randomly divided into a study group and a control group. The results indicate that in the study group, there 603
P. Gilbey et al.
Acupuncture for posttonsillectomy pain in children
was less pain, less analgesic drug consumption, and higher patient/parent satisfaction with analgesic treatment scores. No adverse effects were recorded. Conclusions: Acupuncture, in addition to conventional analgesic treatment, is an effective treatment for posttonsillectomy pain. Acupuncture is safe and well received by children and their parents.
Introduction Tonsillectomy is one of the commonest surgical procedures performed throughout the world. Despite this, there remains significant morbidity associated with the recovery period. Postoperative pain is distressing for the patient and the family, and pain-related poor oral intake can lead to dehydration and inflammation. These complications may be severe enough to require re-hospitalization (1). Doctors have searched for a technique or medication that will produce a ‘painless tonsillectomy’ (2). Studies have looked at preoperative medications, pre- or posttonsillectomy injection of local anesthetics (3), variations in techniques used to remove the tonsils (4), intra-operative medications, partial vs total tonsillectomy (5), and postoperative pain control with acetaminophen/paracetamol, opioids, and nonsteroidal anti-inflammatory drugs (NSAIDS). There is no agreement on any particular medication, technique, or tool to achieve this seemingly impossible goal (5). Two recent systematic reviews of randomized clinical trials evaluating clinical evidence of the efficacy of acupuncture for postoperative pain control have been conducted. One concluded that the evidence for efficacy is suggestive but not definitive (6). The other concluded that perioperative acupuncture may be a useful adjunct for acute postoperative pain (7). Sertel et al. (8) conducted a randomized, prospective study in adult patients evaluating the efficacy of acupuncture for painful dysphagia after tonsillectomy. The authors showed reduction in postoperative tonsillectomy pain without unwanted effects. The use of acupuncture in children is more complex than in adults. A potential difficulty is children’s fear of needles (9). Although a great deal of research has been conducted on the safety and efficacy of acupuncture in adults, acupuncture in the pediatric population has received less attention. A recent paper reviewed the evidence base for the safety and efficacy of acupuncture in pediatrics (10). Nine randomized controlled clinical trials that detailed the occurrence of adverse events in children, if any, were included. The incidence of side effects was estimated to be 1.55/100 treatments. Puncture redness was the most commonly reported unwanted effect. The risk of serious adverse events was 5.36/10 000 treatments. The National Institutes of Health Consensus Statement (11) states that 604
one of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted procedures for the same conditions. Shenkman et al. (12) evaluated acupressure–acupuncture antiemetic prophylaxis in children undergoing tonsillectomy. Redness occurred in 8.5% of acupuncture sites. Ochi (13) conducted a retrospective review of 31 juvenile patients receiving acupuncture for posttonsillectomy pain. This report showed a significantly reduced pain score immediately after treatment. However, the treatment was initiated up to 10 days after surgery, and the study sample was a sample of convenience, employing neither random assignment nor control conditions against which to compare the acupuncture treatment. Both the researcher and the patients were motivated to see pain reduced. To our knowledge, acupuncture has not yet been evaluated by a randomized controlled study as treatment for posttonsillectomy pain in children. The objective of this study was to assess whether in-hospital postoperative treatment of children undergoing tonsillectomy with acupuncture reduces pain, and to examine possible unwanted effects of this treatment. We hypothesized that acupuncture, in addition to conventional analgesic treatment, would be effective in the treatment of posttonsillectomy pain in children and would be well received by children and their parents. Methods A randomized, controlled, single-blinded study comparing conventional postoperative analgesia consisting of paracetamol-on-demand with the same regime plus acupuncture was performed. The study is in accordance with the ethical standards of the Helsinki Declaration and was approved by the Human Experimentation Ethics Committee of the Ziv Medical Center and the Israeli Ministry of Health. Patients were recruited through the preoperative clinic conducted on the day before surgery. All parents and children were recruited for the study before randomization, and given a full explanation of the study by an experienced member of the research team. Written informed consent was obtained before randomization from the parents or guardians of the children who served as subjects of the investigation. Children aged 3–12 years undergoing tonsillectomy, with or © 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 603–609
P. Gilbey et al.
without adenoidectomy, were included in the study. Indications for surgery included tonsillar hypertrophy with sleep disordered breathing and/or recurrent tonsillar infections. Exclusion criteria were lack of parental consent, skin lesions near acupuncture sites, psychiatric disorders, coagulopathy, drug allergies to regular analgesic treatment, intake of medications possibly affecting postoperative pain, and previous acupuncture treatment of the child or his/her immediate family. Patients were randomized into two treatment groups. The randomization was performed by allocating the first patient to register at the clinic to the study group, the second to the control group, the third to the study group, and so on. The patients were booked into the clinic by the secretariat without the knowledge of the study team, and the order of registration to the clinic was unaffected by any potential confounding factor. Both groups underwent tonsillectomy using sharp and blunt cold dissection. This pilot study was limited by budget, but to ensure correct use of parametric statistical tests, both the acupuncture treatment group and the control group included 30 participants. Hemostasis was achieved by local pressure and by minimal, low-power, short-duration monopolar electrocautery if needed. If necessary, sutures were used to control bleeding. All patients received general anesthesia using standard and uniform anesthetic technique including routine perioperative administration of dexamethasone in accordance with the 2011 American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) practice guidelines (14). Intra-operative analgesia included i.v. fentanyl 2 lgkg 1 and i.v. paracetamol 15 mgkg 1. Initial postoperative pain control included i.v. pethidine 0.1 mgkg 1 in postanesthetic recovery unit. All the patients received oral analgesic treatment according to a standard protocol in the pediatrics department (described below). The acupuncture group received, in addition, acupuncture according to accepted Chinese medical techniques. All acupuncture treatments were performed by the same member of the research team (YA) who has wide experience in performing pediatric acupuncture, using the same type of needles, the same points, and the same depth of penetration. Sterile, disposable, FDA-approved acupuncture needles (0.20 * 15 mm; Dong Bang Acupuncture Inc., Chungnam, Korea) were used. Acupuncture was performed bilaterally on each patient. Altogether six needles were used. The needles penetrated the skin to a depth of 5– 10 mm and were kept in place for no more than 5 min. The acupuncture points used were: LI 4 (Hand), LI 11 (Elbow), and St 44 (Foot), according to Chinese acupuncture mapping (15–17). Treatment was repeated three times during the hospital stay. The first treatment © 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 603–609
Acupuncture for posttonsillectomy pain in children
was given approximately 2 h after discharge from the postoperative unit. The second treatment was given on the same evening, approximately 4–8 h after the first treatment, and the third treatment was given the following morning, approximately 12–18 h after the second treatment. Exact treatment times were recorded in the patient’s file. All treatments were performed in a designated room outside the pediatric ward. Children in the control group were also removed from the pediatric ward at treatment times and were interviewed about their postoperative recovery. These interviews were conducted in the same designated room under the same conditions as the acupuncture group. According to standard operating procedure in the pediatric department, every child was treated with oral paracetamol using a standard dosage regime of 10 mgkg 1 per dose (18) by request every 4–6 h and not more than five doses in 24 h, and not continuously for more than 3 days postoperatively. Oral analgesia by request and not at regular intervals is the accepted postoperative analgesic treatment protocol in our institute. In addition, oral ibuprofen 10 mgkg 1 per dose was given on request only, no more than three doses in 24 h, in cases in which oral paracetamol was not sufficient for pain control. The primary outcome was postoperative pain. Pain was assessed using the Wong–Baker faces visual analog pain scale which is a widely used and validated measure of postoperative pain in children (19,20). Pain assessment was done by experienced nursing staff who were not connected to the study and who were unaware of the child’s randomization status. Nurses, parents, and children were repeatedly instructed not to discuss the randomization status of the children. No redness at acupuncture sites was noted, and this could therefore not identify children as belonging to the acupuncture group. Pain scores were recorded in both groups upon arrival at the pediatrics department, upon request of analgesics, and regularly every 4 h until discharge unless the child was asleep. Pain scores were also recorded in both groups immediately before acupuncture treatment times and 1 h after acupuncture treatment times. In addition, parents were asked to score, on a five-point scale (1 = not at all satisfied, 5 = extremely satisfied), their general satisfaction with the postoperative analgesic treatment. Acupuncture treatments took place at least 1 h after intake of oral analgesics to minimize overlapping effects. All children were assessed for side effects of acupuncture by a pediatrician. Specifically, these side effects included pain, tenderness, redness, swelling, or any other unusual skin or soft tissue reaction at the acupuncture points. This study focused on postoperative pain during the first 24 h following surgery, and no evaluation of pain during the following days was performed. 605
P. Gilbey et al.
Acupuncture for posttonsillectomy pain in children
Statistical methods Descriptive Statistics: For categorical variables, summary tables are provided giving sample size, absolute, and relative frequencies. For continuous variables, summary tables are provided giving arithmetic mean (M) and standard deviation (SD). Pearson’s chi-squared or Fisher’s exact test is applied for testing the differences between the study groups for the categorical parameters. The two-sample t-test is applied for testing differences between the study groups for quantitative parameters. All tests applied are two-tailed, and P value of 5% or less is considered statistically significant. The data were analyzed using the SPSS version 20.0.0.2 (SPSS Inc., Chicago, IL, USA). Results Eighty-eight children underwent tonsillectomy at the Ziv Medical Center during the study period. Of these, 28 declined to participate in the study. Sixty children were recruited to the study, and were randomized into two groups: 30 in the acupuncture group and 30 in the control group. Demographic data, indication for surgery, type of surgery performed, and postoperative complications are presented in Table 1. The results of pain scores recorded in the two groups are presented in Figure 1. Compared to the control group, children who received acupuncture had significantly less pain following the second and third treatments (about 8 and 20 h postoperatively, respectively). In both groups, a biphasic pattern of postoperative pain was observed with a tendency to reduced pain 4 h after surgery, and a secondary rise at 8 h, before a final and sustained reduction in pain. However, in the acupuncture group, the reduction in pain following the first treatment (4 h) was substantial and therefore the pain scores preceding the second treatment Table 1 Demographic characteristics of study participants
Age (years)
Acupuncture group (n = 30)
Control group (n = 30)
M
SD
M
SD
5.1 N 17
2.2 % 57
6.1 N 17
2.6 % 57
23 77
8 22
26 73
20 3
5 2
17 7
57 77
22 22
73 73
Male Procedure performed Tonsillectomy 7 Adeno-tonsillectomy 23 Postoperative complications Vomiting 6 Bleeding 1 Indication for surgery Chronic tonsillitis 17 Hypertrophy 23
606
Figure 1 Pain scores (VAS) in both groups before and after treatment times. Arrows designate acupuncture treatment times. Note: a-b, A-B Different letters represent significant differences between groups (P ≤ 0.01).
at 8 h were lower in comparison to the pain scores preceding the first treatment. In contrast, in the control group, the pain scores preceding the second treatment at 8 h postoperatively were higher than the pain scores preceding the first treatment at 4 h postoperatively. Following completion of all the three treatments, the pain scores in the acupuncture group were significantly lower than the control group. The amounts of analgesic drug support required were lower in the acupuncture group in comparison to the control group (Table 2). The overall analgesic drug consumption and the paracetamol consumption were significantly lower, whereas the ibuprofen consumption was lower but not significantly so. Average overall patient/parent satisfaction with analgesic treatment scores were significantly higher in the acupuncture group than in the control group (Table 2). No children or parents elected to end their participation in the study after receiving the first or second acupuncture treatment. No adverse effects as a result of the acupuncture treatments were recorded. Discussion Posttonsillectomy pain represents a significant problem and is therefore of great clinical interest. In the first study to compare the analgesic efficacy of acupuncture to a nonspecific acupuncture control (sham acupuncture) and a nonacupuncture standard medica© 2015 John Wiley & Sons Ltd Pediatric Anesthesia 25 (2015) 603–609
P. Gilbey et al.
Acupuncture for posttonsillectomy pain in children
Table 2 Analgesic medication consumption and parental satisfaction with pain control in both groups
Paracetamol (total number of doses administered) Ibuprofen (total number of doses administered) Paracetamol and ibuprofen (total number of doses administered) Parental satisfaction with postoperative analgesic treatment (1–5)
Acupuncture group
Control group
M
SD
M
SD
1.0 0.8 1.8
0.9 0.7 1.1
1.5 1.1 2.5
1.1 1.0 1.4
0.050 0.179 0.020
4.8
0.6
3.9
1.0
