What literature is available on the use of remifentanil PCAs in the OB patient population? Are there specific dosing recommendations for patients who are not mechanically ventilated?

Comment by InpharmD Researcher

A moderate body of literature supports the use of remifentanil PCA for labor analgesia in spontaneously breathing, nonmechanically ventilated women, although dosing protocols vary and the optimal bolus dose remains uncertain. Remifentanil PCA generally provides better analgesia than other systemic opioids but less effective analgesia than epidural analgesia, with maternal respiratory depression, apnea, and oxygen desaturation representing important safety concerns. Current guidance supports demand-only PCA dosing without a continuous background infusion with a 2-minute lockout; the OAA recommends an initial 20-30 mcg bolus with adjustment to 10-20 mcg or 30-40 mcg based on analgesia and adverse effects, whereas NICE recommends considering a 40 mcg bolus. Continuous observation of breathing and pulse oximetry, one-to-one supervision, immediately available supplemental oxygen, and immediate anesthetic support are emphasized during administration.

The literature was searched using “remifentanil,” “patient-controlled analgesia,” “PCA,” “obstetric,” “labor analgesia,” “dosing,” and “respiratory depression.” Relevant trials, systematic reviews, and guidelines were evaluated for efficacy, safety, and dosing in nonmechanically ventilated women during labor.

Background

According to the 2026 Obstetric Anaesthetists’ Association (OAA) guidelines on remifentanil patient-controlled analgesia (PCA) for labour analgesia, remifentanil PCA provides effective labour analgesia, with better pain relief than other parenteral opioids or nitrous oxide alone but less effective analgesia than epidural analgesia. The guidelines recommend administration as PCA demand boluses without a continuous background infusion, using a 2-minute lockout and an incremental dosing approach starting at 20–30 mcg per bolus, with reduction to 10–20 mcg or escalation to 30–40 mcg based on analgesia and adverse effects. Continuous oxygen saturation monitoring and uninterrupted one-to-one observation are recommended due to risks of sedation, respiratory depression, desaturation, and apnea; supplemental oxygen should be administered when SpO₂ falls below 94%. Although multiple dosing regimens have been studied, the optimal bolus dose remains uncertain, and further research is needed. [1]

The 2026 National Institute for Health and Care Excellence (NICE) guideline on intrapartum care evaluates intravenous remifentanil PCA as an option for ongoing pain relief during labor and birth. NICE recommends considering 40 mcg per PCA bolus with a 2-minute lockout period, with this dose selected based on the more recent and larger studies and its use in clinical practice. Compared with intramuscular pethidine, remifentanil PCA was associated with fewer requests for epidural analgesia and forceps or ventouse births and more spontaneous vaginal births, but with greater supplemental oxygen requirements and reduced maternal oxygen saturation; maternal respiratory rate <8 breaths/min, cesarean birth, labor pain, and maternal satisfaction were similar between groups. Due to the risk of maternal respiratory depression, remifentanil PCA should only be used in obstetric units with continuous one-to-one care, respiratory observation and pulse oximetry, immediately available supplemental oxygen, established procedures for respiratory depression, and immediate anesthetic support. NICE noted concerns regarding the quality and heterogeneity of the evidence, which limited the strength of its recommendation. [2]

A 2025 narrative review evaluated the efficacy, safety, and dosing of remifentanil PCA for labor analgesia. Remifentanil PCA provided mild-to-moderate pain relief and was less effective than epidural analgesia but more effective than nitrous oxide and other systemic opioids; reported regimens generally used 10–50 mcg boluses with a 2-minute lockout, with or without background infusion. The authors’ institutional protocol uses 20–40 mcg boluses with a 2-minute lockout and no continuous background infusion, starting at the lower end and increasing stepwise based on pain, respiratory parameters, and sedation. Maternal respiratory depression, apnea, and transient oxygen desaturation were identified as safety concerns, and the review emphasized incremental dosing, continuous monitoring, supplemental oxygen, one-to-one supervision, and anesthesia team availability. [3]

A comprehensive review states higher bolus doses of remifentanil may provide better analgesia but more maternal side effects, while lower bolus doses can produce fewer side effects but inadequate analgesia. One study demonstrated that remifentanil intravenous PCA with a bolus dose of 0.25 to 0.5 mcg/kg without a background infusion significantly reduced pain scores from baseline in 90% of the patients with minimal maternal and neonatal adverse effects. [4]

A dose-finding study observed the median effective PCA bolus dose of remifentanil to be 0.4 mcg/kg, but there was a wide individual variation of 0.2 to 0.8 mcg/kg. They reported slight sedation in all patients, oxygen desaturation (defined by a SpO2 <94%) in 59% of women, fetal heart rate changes in 24% of women, and low Apgar scores in 5.8% of neonates. More recently, a stepwise increase in the bolus dose of PCA remifentanil for labor analgesia was investigated, starting from 0.15 mcg/kg without a maximum limit. They found a significant reduction in the mean pain scores in the first 3 hours and high patient satisfaction in 93% of women. They, however, noted a reduction of respiratory rate and oxygen saturation, without any serious complications, in mothers or neonates. [4]

In an attempt to determine the optimum dose of remifentanil IV PCA for labor analgesia, one study compared variable infusion (0.025 to 0.1 mcg/ kg/min with constant bolus of 0.25 mcg/kg), with variable boluses (0.25 to 1 mcg/kg with constant infusion at 0.025 mcg/kg/min). The pain scores, satisfaction scores, and cumulative doses of remifentanil were found to be similar between the two groups but maternal side effects such as drowsiness and desaturation were higher in the variable bolus group than the variable infusion group. As a result, they concluded that the regimen of increasing background infusion with a fixed PCA bolus could be more appropriate than fixed background infusion with an increasing PCA bolus. [4]

Another study assessed the efficacy and safety of continuous remifentanil infusion, with no boluses, in 205 parturients. They found that infusing remifentanil starting at a rate of 0.025 mcg/kg/min with stepwise increments to a maximum of 0.15 mcg/kg/min resulted in significant reductions in pain scores from baseline, with minimal maternal and neonatal side effects. There was no case of oxygen desaturation or any changes in heart rate variability. Additionally, a prospective, double-blinded randomized controlled trial comparing maternal and neonatal effects of remifentanil PCA. A stepwise increase in the bolus from 0.1 to 0.4 mcg/kg was compared to continuous infusion with increases from 0.05 to 0.2 mcg/kg/min. It was revealed that the adverse effects were similar between both groups. Results from this trial suggest that remifentanil PCA provides better pain relief and similar placental transfer, but 6 of the women in the trial chose to cross over to epidural analgesia because their analgesia was unsatisfactory, suggesting that the maximum dose in this trial may have been too low. [4]

Labor analgesia with IV remifentanil has been reported to be associated with excessive maternal sedation and oxygen desaturation, as well as fetal heart decelerations, depending on the dose and administration regimen. There was a case of respiratory arrest with bradycardia reported with remifentanil PCA administered with a PCA bolus of 40 mcg, due to unknown reasons. There was another case of cardiorespiratory arrest in a woman who underwent induction of labor using remifentanil PCA, which consisted of 40 mcg given as a bolus with a maximum dose of 5 mg per 4 hours. She had received 60 mg of oral codeine phosphate and diamorphine 10 mg intramuscularly in addition to Entonox during labor. The patient fully recovered after resuscitation but the exact reason for the arrest remains unclear. Remifentanil readily crosses the placenta and neonates could theoretically experience the same side effects as their mothers but there were no case reports/studies of serious neonatal adverse events. [4]

A meta-analysis compared the efficacy and safety of remifentanil PCA and epidural analgesia for labor pain relief from five randomized, controlled trials. It was determined that remifentanil PCA does not provide better analgesic efficacy than epidural analgesia during labor but could be an optional effective alternative for pain relief. The safety of remifentanil still remains controversial, but it has been reported that maternal sedation and respiratory depression may occur during labor with remifentanil use. Therefore, remifentanil PCA requires monitoring, one-on-one nursing care throughout labor, and supplemental oxygen in some parturients. [5]

A Cochrane review and meta-analysis included 20 randomized controlled trials of women receiving remifentanil PCA compared to other methods of parental pain management during labor. Evidence showed women in the remifentanil PCA group were more satisfied with pain relief than women in the other opioids group (95% confidence interval [CI] 0.72 to 3.49). There is evidence that remifentanil PCA provided stronger pain relief at one hour than other opioids (95% CI -2.96 to -0.48). [6]

There is no evidence that remifentanil PCA was associated with an increased risk for maternal respiratory depression when compared to epidural analgesia (relative risk [RR] 0.91, 95% CI 0.51 to 1.62). Additionally, there is no evidence that remifentanil PCA was associated with an increased risk for newborns with Apgar scores less than seven at five minutes compared to epidural analgesia (RR 1.26, 95% CI 0.62 to 2.57). There is evidence, however, that remifentanil PCA was associated with a lower risk for the requirement of additional analgesia when compared to other opioids (RR 0.57, 95% CI 0.40 to 0.81). [6]

A 2017 meta-analysis including eight randomized controlled trials (N= 2,351 patients) investigated whether remifentanil patient-controlled analgesia (R-PCA) is associated with significant differences in maternal satisfaction, analgesic efficacy, and safety compared to conventional epidural analgesia (EA). The pooled data analysis did not demonstrate a significant difference in the primary outcome of maternal satisfaction between the groups. Hypoxemia incidence was higher in R-PCA compared to EA (odds ratio [OR] 7.48, 95% confidence interval [CI] 3.42 to 16.36). The visual analog pain score at 1 hour was slightly higher with R-PCA versus EA (weighted mean difference [WMD] 1.33, 95% CI 0.30 to 2.36). R-PCA resulted in reduced pruritus incidence versus EA (OR 0.54, 95% CI 0.32 to 0.89). There were insignificant differences in Visual Analog Score for Pain (VAS) at 2 and 3 hours; the need for a cesarean section; respiratory depression; umbilical pH; neonatal Appearance, Pulse, Grimace, Activity, and Respiration score at 1 and 5 minutes; and incidence of nausea and vomiting. Overall, this meta-analysis remains underpowered and is subject to publication biases for several outcomes, including the primary end-points. The results of this meta-analysis should be interpreted with caution, given the heterogeneity among its studies. [7]

Another meta-analysis provides quality evidence that a remifentanil PCA provides better analgesia for labor than intramuscular or intravenous pethidine with almost comparable maternal adverse effects. However, epidural analgesia was found to provide better pain relief than remifentanil. The conclusions of the comparison of remifentanil with inhalational nitrous oxide and fentanyl are less clear due to limited data. As there were few randomized trials included in the meta-analysis, with few adverse effects reported, an appropriate risk-to-benefit analysis is currently not possible. Large randomized controlled trials reporting on safety issues and patient satisfaction using appropriate administration modes are needed to complement the knowledge of this alternative method for pain relief during labor. [8]

Background References: [1] Hughes DA, Broom MA, Eley VA, et al. Remifentanil patient-controlled analgesia for labour analgesia: guidance from the obstetric anaesthetists' association: Recommendations for well tolerated provision of remifentanil PCA for labour analgesia. Eur J Anaesthesiol. 2026;43(6):486-498. doi:10.1097/EJA.0000000000002373
[2] National Institute for Health and Care Excellence. Intrapartum care. NICE guideline NG235. Updated June 9, 2026. https://www.nice.org.uk/guidance/ng235
[3] Vovk Racman P, Lučovnik M, Stopar Pintarič T. Current Perspectives on Remifentanil-PCA for Labor Analgesia: A Narrative Review. Medicina (Kaunas). 2025;61(9):1550. Published 2025 Aug 29. doi:10.3390/medicina61091550
[4] Ohashi Y, Baghirzada L, Sumikura H, Balki M. Remifentanil for labor analgesia: a comprehensive review [published correction appears in J Anesth. 2017 Feb;31(1):160]. J Anesth. 2016;30(6):1020-1030. doi:10.1007/s00540-016-2233-y
[5] Liu ZQ, Chen XB, Li HB, Qiu MT, Duan T. A comparison of remifentanil parturient-controlled intravenous analgesia with epidural analgesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2014;118(3):598-603. doi:10.1213/ANE.0000000000000077
[6] Weibel S, Jelting Y, Afshari A, et al. Patient-controlled analgesia with remifentanil versus alternative parenteral methods for pain management in labour. Cochrane Database Syst Rev. 2017;4(4):CD011989. Published 2017 Apr 13. doi:10.1002/14651858.CD011989.pub2
[7] Lee M, Zhu F, Moodie J, Zhang Z, Cheng D, Martin J. Remifentanil as an alternative to epidural analgesia for vaginal delivery: A meta-analysis of randomized trials. J Clin Anesth. 2017;39:57-63. doi:10.1016/j.jclinane.2017.03.026
[8] Schnabel A, Hahn N, Broscheit J, et al. Remifentanil for labour analgesia: a meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2012;29(4):177-185. doi:10.1097/EJA.0b013e32834fc260
Literature Review

A search of the published medical literature revealed 3 studies investigating the researchable question:

What literature is available on the use of remifentanil PCAs in the OB patient population? Are there specific dosing recommendations for patients who are not mechanically ventilated?

Level of evidence

B - One high-quality study or multiple studies with limitations  Read more→



Please see Tables 1-3 for your response.


 

Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial

Design

Open-label, multicenter, randomized controlled trial

N= 401

Objective

To evaluate epidural analgesia progression among women using remifentanil patient-controlled analgesia (PCA) compared with pethidine

Study Groups

Remifentanil PCA (n= 201)

Pethidine (n= 199)

Inclusion Criteria

Age ≥ 16 years, > 37 weeks' gestation, singleton live baby, cephalic presentation, in established labor (defined as regular painful contractions irrespective of cervical dilatation) and intending vaginal birth

Exclusion Criteria

Did not request opioid analgesia or had received opioid analgesia in the preceding 4 hours, had contraindications to remifentanil, pethidine, or epidural analgesia, participating in a separate drug trial

Methods

Patients were randomized (1:1) to receive either intravenous remifentanil PCA or intramuscular pethidine. The PCA pump was pre-programmed with a regimen that provided a bolus of 40 μg remifentanil on demand, with a lockout interval of 2 minutes during which further remifentanil could not be received. If excess sedation occurred, the regimen was reduced to 30 μg with a lockout interval of 2 minutes. Patients in the pethidine group received pethidine 100 mg intramuscularly up to every 4 hours (maximum dose of 400 mg in 24 hours).

Duration

May 2014 to September 2016

Outcome Measures

Primary: proportion of women who had an epidural placed for pain relief in labor

Secondary: adverse safety outcome; effectiveness of pain relief (evaluated by visual analogue scale [VAS] pain score); delivery mode; excessive sedation score ≥ 4; respiratory depression; oxygen saturation < 94% while breathing room air; requirement for supplemental oxygen and antiemetic administration; maternal satisfaction with pain relief; requirement for expedited interventional delivery to resolve fetal distress; persistent low Apgar score at 5 minutes (Apgar score ≤ 4); fetal acidosis; requirement for neonatal resuscitation; admission to neonatal special care; rate of initiation of breastfeeding within the first hour of birth

Baseline Characteristics

 

Remifentanil PCA (n= 201)

Pethidine (n= 199)

   

Age, years

29.4 ± 6.1 29.3 ± 6.1    

Weight, kg

73.1 ± 18.4 74.0 ± 17.2    

White

146 (73%) 157 (79%)    

Current pregnancy

Induced

Pre-eclampsia

Continuous electronic fetal monitoring

Syntocoinon commenced before randomization


137 (68%)

8 (4%)

188 (94%)

100 (50%)


136 (68%)

8 (4%)

184 (92%)

103 (52%)

   

Results

 

Remifentanil PCA (n=201)

Pethidine (n=199)

Risk ratio (95% confidence interval)

p-value

Received epidural

39 (19%) 81 (41%) 0.48 (0.34 to 0.66) < 0.0001

Average median VAS pain score

50.67 64.58 Treatment difference: -13.91 (-21.40 to -6.43) 0.0003

Delivery mode

Spontaneous vaginal

Instrumental

Cesarean section


128 (64%)

31 (15%)

42 (21%)


106 (53%)

52 (26%)

41 (21%)

- 0.02

Respiratory depression 

1 (1%)

0

-

1.00

Excessive sedation

2 (1%)

3 (2%)

0.54 (0.09 to 3.20)

0.49

Low oxygen saturation

26 (14%)

8 (5%)

2.65 (1.23 to 5.68)

0.007

Supplemental oxygen

35/76 (46%)

1/76 (1%)

35 (4.92 to 249.02)

< 0.0001

Antiemetic administration

42 (21%)

134 (68%)

0.31 (0.23 to 0.41)

< 0.0001

Satisfied with labor pain relief

Strongly disagree

Disagree

Neutral

Agree

Strongly agree


3 (2%)

9 (5%)

11 (6%)

44 (24%)

117 (64%)


6 (3%)

13 (7%)

23 (13%)

60 (34%)

74 (42%)

 

0.0003

Interventional delivery for fetal distress

29 (14%)

51 (26%)

0.56 (0.37 to 0.85)

0.005

Persistent low Apgar score

0

0

-

-

Fetal acidosis

2 (2%)

1 (1%)

2.18 (0.20 to 23.64)

0.51

Neonatal resuscitation 

20 (10%)

21 (11%)

0.94 (0.53 to 1.68)

0.84

Admission to higher level care

8 (4%)

9 (5%)

0.88 (0.35 to 2.23)

0.79

Breastfeeding within first hour of birth

90 (46%)

91 (47%)

0.99 (0.80 to 1.22)

0.92

Adverse Events

No serious adverse events or drug reactions directly related to either analgesic were reported to occur.

Study Author Conclusions

Intravenous remifentanil PCA for pain relief in labor significantly reduced progression to epidural analgesia in comparison with intramuscular pethidine. An increased proportion of low maternal oxygen saturation and additional requirement for oxygen supplementation was observed with remifentanil than with pethidine; however, it did not result in adverse maternal or neonatal sequelae.

InpharmD Researcher Critique

There was an inability to mask clinical staff and women to the treatment allocation, which was inevitable due to the dissimilar technical aspects of intravenous PCA and intramuscular injection. This appears to be the most robust study evaluating the use of remifentanil PCA.

 

Table 1 References:
[9] Wilson MJA, MacArthur C, Hewitt CA, et al. Intravenous remifentanil patient-controlled analgesia versus intramuscular pethidine for pain relief in labour (RESPITE): an open-label, multicentre, randomised controlled trial. Lancet. 2018;392(10148):662-672. doi:10.1016/S0140-6736(18)31613-1

 

Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia: a randomised equivalence trial

Design

Open-label randomized controlled equivalence trial

N= 409

Objective

To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk laboring women

Study Groups

RPCA (n= 203)

Epidural (n= 206)

Inclusion Criteria

Low-risk women (uneventful medical and obstetric history and uncomplicated pregnancy), beyond 32 weeks of gestation under the care of primary-care midwives

Exclusion Criteria

Younger than 18 years, contraindicated to epidural analgesia, hypersensitivity to opioids, labor had already started

Methods

Eligible patients were randomly assigned (1:1) to intravenous RPCA or EA. Women in the RPCA group received intravenous (IV) 30 mcg boluses (solution 20 mcg/mL) with a lockout time of 3 minutes and without background infusion and were instructed to use the bolus dose immediately before the anticipated contraction. Increased bolus dose up to 40 mcg was allowed in case of insufficient pain relief. Women in the EA group received a loading dose of 25 mg (12.5 mL ropivacaine 0.2%) and continuous infusion of ropivacaine 0.1% plus sufentanil 0.5 mcg/mL. The rate of continuous infusion was decided by the anesthetist following local protocol. Additional boluses were used for inadequate levels of analgesia.

Switch-over to the other treatment group was allowed if patients had insufficient pain control with their initially allocated pain management. Maternal satisfaction with labor pain scores and pain intensity scores were assessed hourly from the start of active labor on a ruler with a Visual Analog Scale (VAS) ranging from 0 to 10 cm (highly dissatisfied or satisfied regarding the pain, respectively). An equivalence margin of 10% was used for the summed-area under the curve (AUC) for satisfaction with pain relief. 

Duration

Between November 2012 and June 2013

Assessment: during active laboring

Outcome Measures

Primary: satisfaction with pain relief 

Secondary: overall satisfaction with pain relief, pain intensity scores during labor, maternal and neonatal outcomes 

Baseline Characteristics

 

RPCA (n= 203)

Epidural (n= 206)

 

Age

Maternal age, years 

Gestational age, weeks

 

31.7

36.1

 

31.8

36.1

 

White

90% 92%  
Body mass index, kg/m2 22  23  

Parity 

0

≥ 1

 

68%

32%

 

91%

29%

 

Results

Endpoint

RPCA (n= 203)

Epidural (n= 206)

p-value

Pain relief, % 

Requested 

Received

 

52%

46%

 

49%

37%

 

0.59

0.05

Mean area under the curve (AUC)

AUC AUC Risk difference (95% confidence interval)

Satisfaction with pain relief

During active labor

During analgesia

 

31

23

 

31

35

 

-0.50 (-6.8 to 5.9)

-12 (-22 to -1.5)

Pain intensity score

During active labor

During analgesia

 

39

29

 

33

17

 

6.4 (0.3 to 13)

12 (3.0 to 21)

The observed value of the AUC for satisfaction with pain relief was comparable between the groups, but equivalence could not be demonstrated statistically. In the subgroup of women who received analgesia, satisfaction with pain relief was significantly lower in the RPCA group. 

Labor characteristics and maternal and neonatal outcomes were comparable in both groups. 

Adverse Events

RPCA vs. Epidural; temperature > 38°C (10% vs. 8%), saturation < 95% (59% vs. 33%, p= 0.002), saturation < 92% (51% vs. 26%), post spinal headache (1% vs. 1%)

There were no serious adverse events.

Study Author Conclusions

In low-risk laboring women, we could not demonstrate equivalence between a strategy with RPCA to EA with respect to satisfaction with pain relief assessed during the total duration of labor. However, once applied satisfaction was higher in women who received epidural analgesia.

InpharmD Researcher Critique

As the study focused on low-risk pregnant women, results may not be applicable to patients with a higher risk of laboring complications. Authors noted missing data measured during delivery, indicating that hourly evaluation of satisfaction with pain control is likely not practical in practice. 



Table 2 References:
[10] Logtenberg S, Oude Rengerink K, Verhoeven CJ, et al. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia: a randomised equivalence trial. BJOG. 2017;124(4):652-660. doi:10.1111/1471-0528.14181

 

Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

Design

Multicenter, randomized, clinical trial

N= 1,414

Objective

To determine women’s satisfaction with pain relief using patient-controlled analgesia (PCA) with remifentanil compared with epidural analgesia during labor

Study Groups

Remifentanil (n= 687)

Epidural (n= 671)

Inclusion Criteria

Healthy or mild systemic disease, aged 18 years or older, scheduled to deliver vaginally after 32 weeks

Exclusion Criteria

Contraindications for epidural analgesia or hypersensitivity to one of the drugs used

Methods

All women were randomized before the start of actual labor to receive either PCA remifentanil or epidural analgesia. The PCA device was programmed to deliver 30 µg remifentanil (solution 20 µg/mL) on request with a lockout time of three minutes. The dose could be increased to 40 µg in case of insufficient pain relief or decreased to 20 µg in case of excessive side effects. If pain relief was inadequate, women could request epidural analgesia. They were advised to discontinue using the device during the second stage of labor to minimize the risk of neonatal side effects.

Epidural analgesia was only given to patients randomized to the epidural group if pain relief was requested. If pain relief after epidural analgesia was found to be inadequate, she could receive PCA remifentanil instead of epidural analgesia.

Duration

May 30, 2011 to October 24, 2012

Outcome Measures

Primary: satisfaction with pain relief (assessed by visual analogue scale [VAS] expressed as the area under the pain satisfaction curve [AUC])

Secondary: AUC for pain intensity scores, score for overall satisfaction with pain relief during labor, highest pain intensity score during labor, pain intensity and satisfaction with pain relief at moment of request for pain relief, highest score for satisfaction with pain relief after pain relief was used, mean scores of pain and satisfaction with pain relief

Baseline Characteristics

 

Remifentanil (n=687)

Epidural (n=671)

 

 

Age, years 

31.5 ± 5.1 31.7 ± 4.8    

White

579 (88%) 561 (90%)    

Body mass index, kg/m² (range)

23.7 (21.5 to 26.9) 23.8 (21.4 to 27.6)    

Gestational age at randomization, weeks (range)

37.8 (35.5 to 39.2) 37.1 (35.3 to 39.0)    

Results

Mean AUC

Remifentanil (n= 687)

Epidural (n= 671)

Difference (95% CI)

p-value

Satisfaction with pain relief during active labor*

30.9 33.7 -2.8 (-6.9 to 1.3)  -

Satisfaction with pain relief after pain relief*

25.6

36.1

-10.4 (-13.9 to -7.0) -

Pain during active labor*

30.9

27.2

3.8 (0.92 to 6.6) -

Pain score after pain relief*

26.7

20.3

6.4 (3.5 to 9.4) -

Satisfaction with pain relief during active labor**

27.2 37.6 -10.3 (-14.6 to -6.1)  -

Satisfaction with pain relief after pain relief**

25.5 41.3 -15.7 (-20.2 to -11.2) -

Pain during active labor**

29.7 24.9 4.9 (1.7 to 8.1) -

Pain score after pain relief**

27.8 21.0 7.0 (3.3 to 10.7) -

VAS scores

       

Satisfaction with pain relief during active labor

5.1 ± 2.3 5.9 ± 2.5 -0.77 (-1.1 to -0.43) < 0.001

Satisfaction with pain relief after pain relief

5.3 ± 2.3 7.0 ± 2.5 -1.7 (-2.1 to -1.3) < 0.001

Satisfaction with pain relief at request for pain relief

4.2 4.3 -0.12 (-0.58 to 0.35) 0.63

Highest satisfaction with pain relief after pain relief

6.9 ± 2.7 8.4 ± 2.3 -1.5 (-2.0 to -1.1) < 0.001

Pain during active labor

6.0 ± 1.9 5.2 ± 2.3 0.74 (0.46 to 1.0) < 0.001

Pain after pain relief

6.1 ± 1.9 4.2 ± 2.3 1.9 (1.5 to 2.3) < 0.001

Pain at request for pain relief

7.7 ± 2.4 7.7 ± 2.5 0.03 (-0.32 to 0.38) 0.87

Lowest pain score after pain relief

4.0 ± 2.6 1.7 ± 2.3 2.3 (1.9 to 2.7) < 0.001

*Missing AUC values imputed

**Missing AUC values not imputed

Adverse Events

Serious Adverse Events: One woman who received epidural analgesia presented with eclampsia on the fourth day after delivery. No maternal deaths occurred. There were three intrauterine fetal deaths after randomization, all before the start of labor.

Study Author Conclusions

Patient-controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia.

InpharmD Researcher Critique

Blinding was not possible because of the nature of the two interventions. There was a large percentage of missing values. The AUC for satisfaction with pain relief during active labor could not be calculated for 57% of women in the remifentanil group and 43% in the epidural group.

 

Table 3 References:
[11] Freeman LM, Bloemenkamp KW, Franssen MT, et al. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial. BMJ. 2015;350:h846. Published 2015 Feb 23. doi:10.1136/bmj.h846