Original Article
Patient-controlled intranasal fentanyl analgesia: a pilot study to assess practicality and tolerability during childbirth

https://doi.org/10.1016/j.ijoa.2014.11.006Get rights and content

Highlights

  • Intranasal self-administration of fentanyl for analgesia in childbirth was assessed in a pilot study.

  • Intranasal self-administration of fentanyl was associated with few maternal side effects.

  • A trend for increased adverse events and neonatal respiratory support occurred with higher doses.

  • The majority of women reported a willingness to use this analgesic option in the future.

Abstract

Background

Intranasal administration of fentanyl is a non-invasive method of analgesic delivery which has been shown to be effective. This pilot study aimed to assess the practicality and tolerability of patient-controlled intranasal fentanyl for relieving pain during childbirth.

Methods

This prospective, non-randomised, clinical trial recruited women with a singleton pregnancy during November 2009 to October 2011. Exclusion criteria included respiratory disease, gestation <37 weeks and pregnancy complications. The device administered fentanyl 54 μg per spray, incorporating a 3-min lock-out. Data collected included demographics, dose, additional analgesia, adverse events, pain relief and delivery outcomes. Follow-up data were obtained within 48 h regarding tolerability of the device.

Results

The final sample included 32 women: mean age was 28.7 years and gestation 39.8 weeks. Mean fentanyl dose was 734 μg and duration of use was 3.5 h. Most women (78.2%) reported satisfactory to excellent pain relief using the nasal device. Four neonates (12.5%) required bag-mask ventilation at birth: three had adequate respiration within 5 min and one required short-term observation in the special-care nursery. For all items, there was a trend towards an adverse outcome, including neonatal respiratory support, as the dose of fentanyl increased. On follow-up, 84.4% reported they would use intranasal fentanyl for their next childbirth experience.

Conclusions

Patient-controlled intranasal fentanyl provides an acceptable level of analgesia during childbirth. It may, however, increase the risk of neonatal respiratory depression. Future, randomised studies should evaluate the safety and efficacy of patient-controlled intranasal fentanyl compared with existing analgesia options.

Introduction

Childbirth may be the most severe pain experience for many women. In Australia, various methods of analgesia are available including pharmacologic (systemic and neuraxial analgesia)1, 2, 3 and non-pharmacologic techniques (e.g. continuous birthing support, aromatherapy, intradermal water injections, hydrotherapy, massage, acupuncture, maternal movement and positioning).2, 4 Systemic analgesia includes inhaled nitrous oxide and parenteral opioids. In Australia, pethidine has been the traditional opioid of choice.5 Opioid administration is associated with maternal side effects including nausea and vomiting, respiratory depression, and delayed gastric emptying. All opioids cross the placenta, and can result in neonatal side effects including respiratory depression, inhibition of suckling, lower neurobehavioral scores, and delay in effective feeding.6 Doubt has been cast on the suitability of opioid analgesia for pain relief during childbirth because of the high incidence of maternal and neonatal adverse effects and inadequate analgesia.2 In addition, there are considerable doubts about the effectiveness of pethidine, including the slow onset of action.7 A recent Cochrane review identified a lack of research regarding the efficacy of opioid analgesia, the most effective opioid, and strategies to minimize adverse side effects.8 At best, they found moderate maternal satisfaction with opioid analgesia.

Currently, the options for effective analgesia during childbirth are limited. Prolonged and unrelieved pain may cause patient dissatisfaction and is associated with postpartum depression and post-traumatic stress disorder.9, 10 Neuraxial analgesia provides the most effective pain relief without maternal sedation.2 Following neuraxial block, women may be restricted to bed and have limited mobility for a significant period of time which may impact negatively on maternal satisfaction and delivery. Many women choose not to have neuraxial analgesia; for some women it is contraindicated due to medical reasons, for others it is unsuitable due to a fear of needles, or it may be unavailable because of absence of skilled staff (e.g. an anaesthetist to insert the catheter or midwifery staff trained in the management of epidurals). Neuraxial analgesia is associated with an increased risk of instrumental vaginal delivery, prolongation of the second stage of labour and increased oxytocin requirement.11 Leeman et al.12 questioned if the high use of epidural analgesia is really the preference among women in the USA or if it is chosen because there is a lack of acceptable options. They recommended further research investigating women’s preferences regarding analgesia during childbirth.

Fentanyl is a synthetic opioid analgesic and may be administered via several routes, most commonly via epidural or intravenous injection, both of which are invasive. Although fentanyl crosses the placenta, serum fentanyl levels in the fetus have been found to be significantly lower than those in the mother. Furthermore, respiratory depression is rare in babies born to mothers receiving fentanyl either parenterally or via an epidural.13, 14, 15

Maternal satisfaction during birthing has been widely studied. Behaviours that encourage involvement and participation in decision-making during birthing promote feelings of control, coping and feeling supported, facilitating women’s assessment of their birth experience as positive.16 Patient-controlled epidural analgesia has been associated with improved maternal satisfaction and lower volume of local anaesthetic requirement compared with continuous epidural infusion.17

Intranasal fentanyl has been proposed as an alternate, fast-acting and non-invasive method of analgesia that is effective in relieving pain for various conditions including acute and chronic pain,18, 19, 20, 21 burns pain,22, 23 postoperative pain,24, 25, 26 and breakthrough cancer pain.27 Fentanyl administration via an intranasal patient-controlled analgesia (PCA) device has been found to be as effective as intravenous PCA for postoperative analgesia.26, 28 To our knowledge, self-administered intranasal fentanyl has not been reported in the obstetric setting. The administration of patient-controlled intranasal fentanyl (PCINF) may positively affect the birthing experience by virtue of being less invasive and portable, having a short duration of action and being effective in relieving pain during childbirth. This pilot study aimed to assess the practicality and tolerability of PCINF for relieving labour pain.

Section snippets

Methods

This was a prospective, non-randomised, open clinical study registered with the Australian and New Zealand Clinical Trials Registry. Ethics approval was obtained from the Melbourne Health Human Research Ethics Committee. Informed written consent was obtained from all participants in the antenatal period.

Women were recruited from one hospital from November 2009 to October 2011. With over 3500 deliveries per year, it was at the time of the study the third largest obstetric facility in the major

Results

Seventy-nine women were recruited in the antenatal period to participate in the study. However, 44 women did not use the PCINF device as analgesia was not required, the decision was made to deliver by elective caesarean section or an alternate form of analgesia was used. In addition, three further women were excluded from participation due to the need for emergency caesarean section, presentation in second stage and device failure. In regards to the faulty device, contents were not expelled

Discussion

To our knowledge, this is the first study to assess PCINF use during childbirth. This pilot study found that PCINF using a 3-min lock-out device provided a high level of satisfaction. The majority of participants (84.4%) expressed a willingness to use PCINF in future birthing experiences. One of the distinct advantages of PCINF lies with its application as a self-administered analgesic. McCrea and Wright30 found that feelings of personal control positively influence women’s satisfaction with

Disclosure

This work was funded by internal Victoria University and Western Health funding grants. The authors have no conflicts of interest to declare.

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