Intrapartum care
DOI: 10.1111/1471-0528.13249 www.bjog.org
A comparison of fentanyl with pethidine for pain relief during childbirth: a randomised controlled trial J Fleet,a I Belan,a MJ Jones,a S Ullah,a,b AM Cynac,d a
School of Nursing & Midwifery, Flinders University, Adelaide, SA, Australia b Flinders Centre for Epidemiology and Biostatistics, School of Medicine, Flinders University, Adelaide, SA, Australia c Women’s & Children’s Hospital, North Adelaide, SA, Australia d The University of Adelaide, Adelaide, SA, Australia Correspondence: J Fleet, University of South Australia, North Terrace, Adelaide, SA, Australia. Email [email protected] Accepted 27 October 2014. Published Online 5 January 2015.
Objective To compare the efficacy of fentanyl administered via the
subcutaneous (s.c.) or intranasal (i.n.) route with intramuscular (i.m.) pethidine in labouring women requesting analgesia. Design A randomised controlled trial three-armed, parallel-design. Setting A regional hospital and the largest tertiary maternity
centre in South Australia. Sample One hundred and fifty-six healthy parturients birthing at
term. Methods Women were randomised to receive s.c. fentanyl
(n = 53), i.n. fentanyl (n = 52), or i.m. pethidine (n = 51). The outcomes were analysed by intention-to-treat. Main outcome measures Pain scores measured before and
30 minutes after opioid administration. Results All groups reported clinically significant reductions in pain scores (mean range 1.2–1.6; P < 0.001), with no significant differences between groups. Significantly more women in the fentanyl groups reported satisfaction with using the study drug
again, compared with women receiving i.m. pethidine (82.9% i.n. fentanyl, 80.6% s.c. fentanyl, and 44.0% i.m. pethidine; P < 0.01). Women in the fentanyl groups experienced less sedation (i.n. fentanyl 7.3%, s.c. fentanyl 2.9%, i.m. pethidine 44%; P ≤ 0.03), shorter labours by at least 2 hours (P < 0.05), and fewer difficulties establishing breastfeeding (78.8% i.m. pethidine, 39.4% i.n. fentanyl, and 44.0% s.c. fentanyl; P < 0.01). Neonates in the pethidine group were more likely to require nursery admission (P < 0.02). Conclusions Fentanyl administered by s.c. and i.n. routes is as
efficacious in relieving labour pain as i.m. pethidine, but resulted in greater satisfaction, less sedation, shorter labour, fewer nursery admissions, and fewer difficulties in establishing breastfeeding. Fentanyl appears to be a suitable alternative to pethidine when providing parenteral pain relief to labouring women. Keywords Fentanyl, intramuscular, intranasal, labour, pethidine, subcutaneous.
Please cite this paper as: Fleet J, Belan I, Jones MJ, Ullah S, Cyna AM. A comparison of fentanyl with pethidine for pain relief during childbirth: a randomised controlled trial. BJOG 2015;122:983–992.
Introduction Pain management in labour is one of the biggest maternity issues, with the majority of women using pharmacological forms of analgesia during childbirth. Epidural analgesia provides effective pain relief, but is invasive and is associated with adverse effects.1 For women unable or unwilling to use an epidural, pethidine is the most commonly administered opioid for labour pain,1 but has a slow onset and has the potential for adverse effects, in part resulting from the active metabolite norpethidine.2 Norpethidine has been associated with neuronal depression in the neonate
ª 2015 Royal College of Obstetricians and Gynaecologists
for up to 60 hours after birth.3 There are few alternative pharmacological options for women, with choice limited to what is held at the different hospitals.4 Although research suggests that women experience superior satisfaction in pain management in labour with the use of opioids compared with non-opioids,5 practitioners continue to debate which opioid and mode of administration is most effective.4 Advances in pain management have led to the use of faster acting opioids such as remifentanil and fentanyl. Although remifentanil patient-controlled analgesia (PCA) has been shown to provide effective pain relief, caution for
983
Fleet et al.
use in obstetrics has been suggested, with four recent case reports of respiratory and/or cardiac arrest in the past year.6 Advantages of fentanyl include rapid onset, short duration, and no active metabolite. Until recently, with the exception of epidural use, only intravenous (i.v.) fentanyl has been studied in the obstetric setting. When compared with i.v. pethidine, i.v. fentanyl produced fewer adverse effects in the mother and baby,7,8 but this route restricts mobility, and requires venous access and additional resources. In non-obstetric settings fentanyl has been shown to be efficacious when administered by the less invasive intranasal (i.n.) and subcutaneous (s.c.) routes.9,10 A number of hospitals in South Australia have been administering s.c. fentanyl to women in labour; however, only one study has explored the effects of this method.11 Another study reported the safe and effective use of i.n. fentanyl following elective caesarean,12 although to date no studies have examined this method during labour. The objective of this trial was to compare the efficacy of fentanyl administered via the s.c. or i.n. route with intramuscular (i.m.) pethidine for labour analgesia, as measured by pain scores 30 minutes after treatment.
Methods This randomised controlled trial (RCT) was conducted in two settings: the Women’s & Children’s Hospital, which is the largest tertiary referral centre for maternal care in Adelaide; and Gawler Hospital, a regional unit in the outer northern area of Adelaide, South Australia. The administration of i.m. pethidine was the standard practice for providing systemic opioid pain relief in these units. The study protocol was approved by the ethics committees of both participating hospitals, and was implemented according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
requiring medication, phaeochromocytoma, allergy or hypersensitivity to fentanyl or pethidine, reliance on opioid substances, or had taken antidepressants within the previous 14 days, and/or women who required an interpreter or had an intellectual disability. Participants were recruited from 11 January 2011 to 3 April 2013. Written consent was obtained before labour commenced.
Interventions The s.c. fentanyl group Participants received a 200 microgram bolus dose of fentanyl administered subcutaneously. After 1 hour, additional 50 microgram doses could be administered every 15 minutes, as requested, up to a maximum of 650 micrograms. A 24–gauge cannula was inserted by the midwife into the subcutaneous tissue in the subclavicular or upper pectoral regions; 1 ml of 1% plain lignocaine was administered, prior to the first dose of fentanyl (200 micrograms/4 ml). Subsequent doses (50 micrograms/1 ml) of fentanyl were smaller, and therefore did not require local anaesthetic. The i.n. fentanyl group Participants self-administered a 54 microgram (0.18 ml) fentanyl dose sprayed into the nose using a patientcontrolled intranasal analgesia (PCINA) device (Go Medical Industries, Perth, Western, Australia). This device had a 4 minute filling time that acted as a lockout between doses.13 The maximum hourly dose was 600 micrograms, with a maximum total dose of 1200 micrograms. The midwife filled the PCINA device with 600 micrograms/2 ml of intranasal fentanyl solution (Orion laboratories Pty Ltd, Balcatta, Western Australia). Tamper-proof tape was fixed to the actuator and bottle of the device to discourage, and enable the detection of, any tampering of the applicator once given to the woman for use. The PCINA was kept upright to allow the chamber to refill.
Participants Participants were identified through the antenatal clinics of the two sites, as well as through women attending antenatal classes and through one-to-one midwifery group practice. The inclusion criteria were women who birthed at term (37–42 weeks of gestation), planned a vaginal birth, had a viable single fetus, with vertex presentation, no known medical conditions, uncomplicated pregnancy, aged 18 years or older, and had a preference for not using an epidural. Exclusion criteria included women who experienced preterm labour (
DOI: 10.1111/1471-0528.13249 www.bjog.org
A comparison of fentanyl with pethidine for pain relief during childbirth: a randomised controlled trial J Fleet,a I Belan,a MJ Jones,a S Ullah,a,b AM Cynac,d a
School of Nursing & Midwifery, Flinders University, Adelaide, SA, Australia b Flinders Centre for Epidemiology and Biostatistics, School of Medicine, Flinders University, Adelaide, SA, Australia c Women’s & Children’s Hospital, North Adelaide, SA, Australia d The University of Adelaide, Adelaide, SA, Australia Correspondence: J Fleet, University of South Australia, North Terrace, Adelaide, SA, Australia. Email [email protected] Accepted 27 October 2014. Published Online 5 January 2015.
Objective To compare the efficacy of fentanyl administered via the
subcutaneous (s.c.) or intranasal (i.n.) route with intramuscular (i.m.) pethidine in labouring women requesting analgesia. Design A randomised controlled trial three-armed, parallel-design. Setting A regional hospital and the largest tertiary maternity
centre in South Australia. Sample One hundred and fifty-six healthy parturients birthing at
term. Methods Women were randomised to receive s.c. fentanyl
(n = 53), i.n. fentanyl (n = 52), or i.m. pethidine (n = 51). The outcomes were analysed by intention-to-treat. Main outcome measures Pain scores measured before and
30 minutes after opioid administration. Results All groups reported clinically significant reductions in pain scores (mean range 1.2–1.6; P < 0.001), with no significant differences between groups. Significantly more women in the fentanyl groups reported satisfaction with using the study drug
again, compared with women receiving i.m. pethidine (82.9% i.n. fentanyl, 80.6% s.c. fentanyl, and 44.0% i.m. pethidine; P < 0.01). Women in the fentanyl groups experienced less sedation (i.n. fentanyl 7.3%, s.c. fentanyl 2.9%, i.m. pethidine 44%; P ≤ 0.03), shorter labours by at least 2 hours (P < 0.05), and fewer difficulties establishing breastfeeding (78.8% i.m. pethidine, 39.4% i.n. fentanyl, and 44.0% s.c. fentanyl; P < 0.01). Neonates in the pethidine group were more likely to require nursery admission (P < 0.02). Conclusions Fentanyl administered by s.c. and i.n. routes is as
efficacious in relieving labour pain as i.m. pethidine, but resulted in greater satisfaction, less sedation, shorter labour, fewer nursery admissions, and fewer difficulties in establishing breastfeeding. Fentanyl appears to be a suitable alternative to pethidine when providing parenteral pain relief to labouring women. Keywords Fentanyl, intramuscular, intranasal, labour, pethidine, subcutaneous.
Please cite this paper as: Fleet J, Belan I, Jones MJ, Ullah S, Cyna AM. A comparison of fentanyl with pethidine for pain relief during childbirth: a randomised controlled trial. BJOG 2015;122:983–992.
Introduction Pain management in labour is one of the biggest maternity issues, with the majority of women using pharmacological forms of analgesia during childbirth. Epidural analgesia provides effective pain relief, but is invasive and is associated with adverse effects.1 For women unable or unwilling to use an epidural, pethidine is the most commonly administered opioid for labour pain,1 but has a slow onset and has the potential for adverse effects, in part resulting from the active metabolite norpethidine.2 Norpethidine has been associated with neuronal depression in the neonate
ª 2015 Royal College of Obstetricians and Gynaecologists
for up to 60 hours after birth.3 There are few alternative pharmacological options for women, with choice limited to what is held at the different hospitals.4 Although research suggests that women experience superior satisfaction in pain management in labour with the use of opioids compared with non-opioids,5 practitioners continue to debate which opioid and mode of administration is most effective.4 Advances in pain management have led to the use of faster acting opioids such as remifentanil and fentanyl. Although remifentanil patient-controlled analgesia (PCA) has been shown to provide effective pain relief, caution for
983
Fleet et al.
use in obstetrics has been suggested, with four recent case reports of respiratory and/or cardiac arrest in the past year.6 Advantages of fentanyl include rapid onset, short duration, and no active metabolite. Until recently, with the exception of epidural use, only intravenous (i.v.) fentanyl has been studied in the obstetric setting. When compared with i.v. pethidine, i.v. fentanyl produced fewer adverse effects in the mother and baby,7,8 but this route restricts mobility, and requires venous access and additional resources. In non-obstetric settings fentanyl has been shown to be efficacious when administered by the less invasive intranasal (i.n.) and subcutaneous (s.c.) routes.9,10 A number of hospitals in South Australia have been administering s.c. fentanyl to women in labour; however, only one study has explored the effects of this method.11 Another study reported the safe and effective use of i.n. fentanyl following elective caesarean,12 although to date no studies have examined this method during labour. The objective of this trial was to compare the efficacy of fentanyl administered via the s.c. or i.n. route with intramuscular (i.m.) pethidine for labour analgesia, as measured by pain scores 30 minutes after treatment.
Methods This randomised controlled trial (RCT) was conducted in two settings: the Women’s & Children’s Hospital, which is the largest tertiary referral centre for maternal care in Adelaide; and Gawler Hospital, a regional unit in the outer northern area of Adelaide, South Australia. The administration of i.m. pethidine was the standard practice for providing systemic opioid pain relief in these units. The study protocol was approved by the ethics committees of both participating hospitals, and was implemented according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.
requiring medication, phaeochromocytoma, allergy or hypersensitivity to fentanyl or pethidine, reliance on opioid substances, or had taken antidepressants within the previous 14 days, and/or women who required an interpreter or had an intellectual disability. Participants were recruited from 11 January 2011 to 3 April 2013. Written consent was obtained before labour commenced.
Interventions The s.c. fentanyl group Participants received a 200 microgram bolus dose of fentanyl administered subcutaneously. After 1 hour, additional 50 microgram doses could be administered every 15 minutes, as requested, up to a maximum of 650 micrograms. A 24–gauge cannula was inserted by the midwife into the subcutaneous tissue in the subclavicular or upper pectoral regions; 1 ml of 1% plain lignocaine was administered, prior to the first dose of fentanyl (200 micrograms/4 ml). Subsequent doses (50 micrograms/1 ml) of fentanyl were smaller, and therefore did not require local anaesthetic. The i.n. fentanyl group Participants self-administered a 54 microgram (0.18 ml) fentanyl dose sprayed into the nose using a patientcontrolled intranasal analgesia (PCINA) device (Go Medical Industries, Perth, Western, Australia). This device had a 4 minute filling time that acted as a lockout between doses.13 The maximum hourly dose was 600 micrograms, with a maximum total dose of 1200 micrograms. The midwife filled the PCINA device with 600 micrograms/2 ml of intranasal fentanyl solution (Orion laboratories Pty Ltd, Balcatta, Western Australia). Tamper-proof tape was fixed to the actuator and bottle of the device to discourage, and enable the detection of, any tampering of the applicator once given to the woman for use. The PCINA was kept upright to allow the chamber to refill.
Participants Participants were identified through the antenatal clinics of the two sites, as well as through women attending antenatal classes and through one-to-one midwifery group practice. The inclusion criteria were women who birthed at term (37–42 weeks of gestation), planned a vaginal birth, had a viable single fetus, with vertex presentation, no known medical conditions, uncomplicated pregnancy, aged 18 years or older, and had a preference for not using an epidural. Exclusion criteria included women who experienced preterm labour (
