A C TA Obstetricia et Gynecologica
AOGS O R I G I N A L R E S E A R C H A R T I C L E
Patient satisfaction between remifentanil patient-controlled analgesia and epidural analgesia for labor pain SASCHA FRAUENFELDER1, RITA VAN RIJN1, CELINE M. RADDER1, MYRTILLE C. DE VRIES2, LEA M. DIJKSMAN3 & MARC B. GODFRIED4 1
Department of Obstetrics and Gynecology, St. Lucas Andreas Hospital, Amsterdam, 2Department of Anesthesiology, St. Lucas Andreas Hospital, Amsterdam, 3Department of Research and Epidemiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, and 4Department of Anesthesiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
Key words Analgesia, obstetrics, labor pain, epidural analgesia, remifentanil, patient-controlled analgesia Correspondence Sascha Frauenfelder, Department of Obstetrics and Gynecology, St. Lucas Andreas Hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, the Netherlands. E-mail: [email protected] Conflict of interest The authors have stated explicitly that there are no conflicts of interest in connection with this article. Please cite this article as: Frauenfelder S, van Rijn R, Radder CM, de Vries MC, Dijksman LM, Godfried MB. Patient satisfaction between remifentanil patient-controlled analgesia and epidural analgesia for labor pain. Acta Obstet Gynecol Scand 2015; 94:1014–1021. Received: 1 November 2014 Accepted: 21 May 2015 DOI: 10.1111/aogs.12694
Abstract Introduction. The aim of this study was to compare patient satisfaction between remifentanil patient-controlled analgesia (RPCA) and epidural analgesia (EA) for labor pain. Material and methods. This prospective cohort study was carried out on primiparous women requesting analgesia for labor at a Teaching Hospital, Amsterdam, the Netherlands. Women self-selected the analgesia of choice (RPCA n = 166 and EA n = 124) and were asked to complete the Woman’s Views of Birth Labour Satisfaction Questionnaire (WOMBSLQ), within 24 h (T0), 3 months (T3) and 6 months (T6) after birth. The WOMBSLQ comprises 11 subscales, including pain during labor and general satisfaction. The main outcome measure was general satisfaction. Results. There was no significant difference in the subscale of general satisfaction with labor and delivery (maximum of 14 points) between both groups at all three time points [median score at T0 for RPCA was 12 vs. 13 for the EA group (p = 0.95); at T3: 12 vs. 12, respectively (p = 0.41); and at T6: 12 vs. 12, respectively (p = 0.69)]. Women in the EA group had significantly better pain relief (maximum of 21 points) at all three time points [median score at T0 for RPCA was 14 vs. 18 for the EA group (p < 0.001); at T3: 13 vs. 17, respectively (p = 0.002); and at T6: 13 vs. 17, respectively (p = 0.003)]. Conclusion. Both self-selected groups did not differ in general satisfaction with labor and delivery at all three time points after birth despite a significantly higher experienced pain in the RPCA group. EA, epidural analgesia; RPCA, remifentanil patient-controlled analgesia; VAS, visual analog scale; WOMBLSQ, Woman’s Views of Birth Labour Satisfaction Questionnaire.
Abbreviations:
Introduction Remifentanil patient-controlled analgesia (RPCA) has been demonstrated to be an effective method of pain relief with favorable pharmacokinetic properties for women during labor (1–6). Remifentanil is an ultra short-acting l-opioid that is metabolized rapidly through non-specific tissue esterases in adults and newborns (6– 8). Its half-life is 3 min, and it is mainly eliminated in the urine. Remifentanil has a rapid onset of action (time
1014
Key Message Offering remifentanil patient-controlled analgesia alongside epidural analgesia for pain relief during labor gives women a choice in pain relief that can add to their general satisfaction with labor and delivery.
ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 1014–1021
S. Frauenfelder et al.
to peak 60–90 s). RPCA is not registered for use during labor, but there are several studies, including in healthy term women, evaluating its clinical efficacy and safety, that have concluded that RPCA provides significant analgesia (1,2,5,8). The main concerns about using RPCA on the labor ward are the rare but severe maternal respiratory side-effects, such as desaturation, hypopnea/apnea and bradycardia. Previous studies have shown that when safety standards are applied by trained professionals, RPCA is safe for both mother and child (9). Epidural analgesia (EA) is considered the gold standard in the Netherlands (10) for pain relief during labor. However, EA has distinct side-effects. Placement of the epidural catheter can cause a post-dural puncture headache, and the first dose of local anesthetics can cause hypotension, resulting in a decrease in placental perfusion. EA is associated with an increased risk for instrumental deliveries (11), and it can cause an increase in body temperature, potentially masking a maternal infection (12). Finally, mothers with EA sometimes describe feelings of being a spectator in their own labor (13). Opioids such as pethidine (meperidine) are in widespread use as an alternative for labor pain control, but are known to give inadequate pain relief with maternal and neonatal side effects. RPCA has been shown to be more effective than traditional opioids for labor pain relief (14). In addition to the traditional forms of labor analgesia such as pethidine (meperidine) and EA, RPCA is gaining popularity for the purpose of labor analgesia. This is noteworthy because studies comparing RPCA with EA found significantly higher pain scores for the RPCA group (3,6,15– 17). Four studies comparing RPCA with EA showed that EA is a better analgesic, but maternal satisfaction scores were comparable for both, with no differences in type of delivery or neonatal outcome (6,15–17). These studies had limitations in measurement of maternal satisfaction, which was measured during and/or directly after birth. Waldenstrom (18) found that measurements of satisfaction with childbirth made soon after delivery might be biased. Recently, a large randomized multicenter trial (3) performed in the Netherlands found that both the woman’s satisfaction and the pain relief performance with RPCA was significantly less than with EA. Scores of satisfaction with the pain were limited to the period during labor and directly post labor. All these previous studies focus on pain relief and satisfaction during and directly after birth. No studies have evaluated the overall satisfaction with labor between RPCA and EA at various times after birth. In the Netherlands currently, more than 20 hospitals use RPCA on their labor wards. At one of our institutions, the St. Lucas Andreas Hospital, the clinical experience with RPCA has been good. A short retrospective
Remifentanil versus epidural for labor pain
study prior to the current study was promising, and no side-effects for mother and baby were seen (Frauenfelder S., Radder C. M. & Godfried, M. B., unpublished data). Over the past 3 years, the request for RPCA for delivery has increased at St. Lucas Andreas Hospital. The growing popularity of RPCA and the discrepancy between the higher pain scores was an incentive for us to compare patient satisfaction with EA at three time points after childbirth. In this study, we compared RPCA with EA for labor pain, with the primary outcome being patient satisfaction. The secondary outcome was pain reduction.
Material and methods The Medical Ethical Committee of the St. Lucas Andreas Hospital approved the study protocol (NL17308.029.07). The study design was originally designed as a randomized controlled trial in 2007. We continued to carry out the randomized controlled trial comparing RPCA with EA in healthy primiparous women during active labor for at least 1 year. We were only able to include seven women. More than 100 women refused participation because choice in pain relief is important for women in labor. The question remained whether RPCA could be comparable to EA in terms of a patient’s perception of pain and satisfaction. Based on this, we redesigned the study into a prospective cohort study. St. Lucas Andreas Hospital is one of six obstetric centers (two university centers) in Amsterdam. With 2500 medical deliveries per year, this is a large Dutch obstetric center. In addition, a midwife-led birthing center performs 500 low-risk births a year. Between September 2008 and February 2011, all women with a primary request for analgesia during the first stage of term labor (Figure 1) were asked to participate in our study. The women could choose between RPCA and EA. In the cohort, the selected women were eligible based on the inclusion and exclusion criteria. The inclusion criteria were healthy women with term pregnancies (American Society of Anesthesiologists Physical Status Classification I or II), primiparous women or multiparous women who had never experienced the first stage of labor (primary cesarean delivery), all with uncomplicated singleton pregnancies. Exclusion criteria were women with opiate-related allergies, pethidine (meperidine) intramuscular injection 6 h prior to analgesic request, body mass index >40 kg/ m2 and women with a psychiatric disease history. Women with obstetric conditions such as preeclampsia/eclampsia, HELLP syndrome, severe diabetes, infection/fever and/or placental abnormalities were excluded, as were women with >6 cm cervical dilation. During antenatal care, study information was provided, including a brochure available in different languages. When women had regular contrac-
ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 1014–1021
1015
Remifentanil versus epidural for labor pain
S. Frauenfelder et al.
Inclusion and exclusion criteria
295 patients with labor analgesia request informed consent choice between RPCA and EA
5 patients excluded due to incomplete confirmed consent and/or medical record.
166 patients received RPCA
124 patients received EA
95%), RPCA was terminated immediately. Naloxone 0.4 mg for intravenous administration was present in the delivery rooms at all times. When systolic blood pressure dropped below 100 mmHg, 500 mL of crystalloid was added. If there was no response within 15 min, RPCA was terminated. Fetal conditions were continuously monitored by cardiotocography. If a suboptimal condition was suspected, fetal scalp blood sampling was used to determine fetal pH, base-excess and pCO2. When serious fetal distress was identified, RPCA was terminated, and maternal and fetal conditions were checked. There was a standby emergency team at all times. For women who requested EA, an anesthetist was called. Each woman was connected to default monitoring equipment, i.e. pulse oximeter, blood pressure measurement, three-channel electrocardiogram and cardiotocography, received a peripheral intravenous line (IV), and was asked to sit in an upright position. An 18-gauge Tuohy
Remifentanil versus epidural for labor pain
epidural needle was inserted at lumbar level 2–3, and correct placement was identified by loss of resistance. A 20gauge catheter was then inserted 3–4 cm into the epidural space. After aspiration with a 2-mL syringe for blood or cerebrospinal fluid, a test bolus of 2–3 mL of 0.25% bupivacaine was given. Subsequently, a maximum of 10 mL bupivacaine 0.25% was administered. The epidural catheter was connected to a syringe in a perfusor with a solution of 0.125% bupivacaine with sufentanil 0.2 lg/mL at 6–8 mL/h continuous dose. The epidural infusion was stopped at the start of the second phase of delivery (active “pushing”) or continued if the patient had a good pushing technique and sufficient progress of labor could be achieved. For the primary outcome of general satisfaction with labor and delivery, all women were asked to fill out a translated version of the Woman’s Views of Birth Labour Satisfaction Questionnaire (WOMBLSQ) (19) at the following three time points: within 24 h after delivery (T0), and at 3 months (T3) and 6 months (T6) after birth. The WOMBLSQ is a validated, quantitative, psychometric, multidimensional maternal satisfaction questionnaire containing questions related to 10 dimensions in addition to general satisfaction (19) (see Table S1). The WOMBLSQ consists of 32 questions, numbered consecutively 1–32; women were not aware of the subscales. The questions were statements that required respondents to mark a seven-point Likert scale from “totally disagree” to “totally agree”. A maximum of seven points per question could be scored. There are between two and five questions for every dimension and general satisfaction; thus there are between 14 and 35 total points per subscale or dimension. Within 24 h after birth, women were asked by a midwife to fill in the WOMBLSQ. At 3 and 6 months after birth, the women were sent the WOMBLSQ by post. If they did not return the questionnaire, a telephone call was made to check the address, and a reminder was sent. If there was still no response, the case was defined as lost to follow up. For the secondary outcome of pain reduction during labor analgesia, we assessed pain using the visual analog scale (VAS) before start of drug analgesia and at 5, 30 and 60 min, and at 2 and 8 h after the start of analgesia administration on a scale from 0 to 10. For the safe use of drug analgesia during labor, we assessed the level of sedation using the Ramsay sedation scale at 5, 30 and 60 min, and at 2 and 8 h after the start of the analgesia on a scale from 1 to 4, with level 1 being anxious, agitated and restless; level 2 being co-operative and oriented; level 3 being calm responsive to commands only and level 4 being asleep, brisk response to stimulus. Until the end of RPCA or EA administration, the continuous maternal pulse oximetry and blood pressures were assessed once every 15 min. After delivery, the type of
ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 1014–1021
1017
Remifentanil versus epidural for labor pain
S. Frauenfelder et al.
Table 1. Baseline characteristics of the study population (primiparous women) requesting labor analgesia. Variable Height (cm)a Weight (kg)a Temperature (C°)a VAS (scale 0–10)a Cervical dilation (cm)b
RPCA (n = 166)
EA (n = 124)
p
166.4 17.8 72.4 14.0 36.9 1.6 8.3 1.6 4 (3–5)
168 7.0 74.0 15.9 36.9 0.5 8.2 1.8 3 (2–4)
0.40 0.29 0.51 0.5
AOGS O R I G I N A L R E S E A R C H A R T I C L E
Patient satisfaction between remifentanil patient-controlled analgesia and epidural analgesia for labor pain SASCHA FRAUENFELDER1, RITA VAN RIJN1, CELINE M. RADDER1, MYRTILLE C. DE VRIES2, LEA M. DIJKSMAN3 & MARC B. GODFRIED4 1
Department of Obstetrics and Gynecology, St. Lucas Andreas Hospital, Amsterdam, 2Department of Anesthesiology, St. Lucas Andreas Hospital, Amsterdam, 3Department of Research and Epidemiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, and 4Department of Anesthesiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
Key words Analgesia, obstetrics, labor pain, epidural analgesia, remifentanil, patient-controlled analgesia Correspondence Sascha Frauenfelder, Department of Obstetrics and Gynecology, St. Lucas Andreas Hospital, Jan Tooropstraat 164, 1061 AE, Amsterdam, the Netherlands. E-mail: [email protected] Conflict of interest The authors have stated explicitly that there are no conflicts of interest in connection with this article. Please cite this article as: Frauenfelder S, van Rijn R, Radder CM, de Vries MC, Dijksman LM, Godfried MB. Patient satisfaction between remifentanil patient-controlled analgesia and epidural analgesia for labor pain. Acta Obstet Gynecol Scand 2015; 94:1014–1021. Received: 1 November 2014 Accepted: 21 May 2015 DOI: 10.1111/aogs.12694
Abstract Introduction. The aim of this study was to compare patient satisfaction between remifentanil patient-controlled analgesia (RPCA) and epidural analgesia (EA) for labor pain. Material and methods. This prospective cohort study was carried out on primiparous women requesting analgesia for labor at a Teaching Hospital, Amsterdam, the Netherlands. Women self-selected the analgesia of choice (RPCA n = 166 and EA n = 124) and were asked to complete the Woman’s Views of Birth Labour Satisfaction Questionnaire (WOMBSLQ), within 24 h (T0), 3 months (T3) and 6 months (T6) after birth. The WOMBSLQ comprises 11 subscales, including pain during labor and general satisfaction. The main outcome measure was general satisfaction. Results. There was no significant difference in the subscale of general satisfaction with labor and delivery (maximum of 14 points) between both groups at all three time points [median score at T0 for RPCA was 12 vs. 13 for the EA group (p = 0.95); at T3: 12 vs. 12, respectively (p = 0.41); and at T6: 12 vs. 12, respectively (p = 0.69)]. Women in the EA group had significantly better pain relief (maximum of 21 points) at all three time points [median score at T0 for RPCA was 14 vs. 18 for the EA group (p < 0.001); at T3: 13 vs. 17, respectively (p = 0.002); and at T6: 13 vs. 17, respectively (p = 0.003)]. Conclusion. Both self-selected groups did not differ in general satisfaction with labor and delivery at all three time points after birth despite a significantly higher experienced pain in the RPCA group. EA, epidural analgesia; RPCA, remifentanil patient-controlled analgesia; VAS, visual analog scale; WOMBLSQ, Woman’s Views of Birth Labour Satisfaction Questionnaire.
Abbreviations:
Introduction Remifentanil patient-controlled analgesia (RPCA) has been demonstrated to be an effective method of pain relief with favorable pharmacokinetic properties for women during labor (1–6). Remifentanil is an ultra short-acting l-opioid that is metabolized rapidly through non-specific tissue esterases in adults and newborns (6– 8). Its half-life is 3 min, and it is mainly eliminated in the urine. Remifentanil has a rapid onset of action (time
1014
Key Message Offering remifentanil patient-controlled analgesia alongside epidural analgesia for pain relief during labor gives women a choice in pain relief that can add to their general satisfaction with labor and delivery.
ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 1014–1021
S. Frauenfelder et al.
to peak 60–90 s). RPCA is not registered for use during labor, but there are several studies, including in healthy term women, evaluating its clinical efficacy and safety, that have concluded that RPCA provides significant analgesia (1,2,5,8). The main concerns about using RPCA on the labor ward are the rare but severe maternal respiratory side-effects, such as desaturation, hypopnea/apnea and bradycardia. Previous studies have shown that when safety standards are applied by trained professionals, RPCA is safe for both mother and child (9). Epidural analgesia (EA) is considered the gold standard in the Netherlands (10) for pain relief during labor. However, EA has distinct side-effects. Placement of the epidural catheter can cause a post-dural puncture headache, and the first dose of local anesthetics can cause hypotension, resulting in a decrease in placental perfusion. EA is associated with an increased risk for instrumental deliveries (11), and it can cause an increase in body temperature, potentially masking a maternal infection (12). Finally, mothers with EA sometimes describe feelings of being a spectator in their own labor (13). Opioids such as pethidine (meperidine) are in widespread use as an alternative for labor pain control, but are known to give inadequate pain relief with maternal and neonatal side effects. RPCA has been shown to be more effective than traditional opioids for labor pain relief (14). In addition to the traditional forms of labor analgesia such as pethidine (meperidine) and EA, RPCA is gaining popularity for the purpose of labor analgesia. This is noteworthy because studies comparing RPCA with EA found significantly higher pain scores for the RPCA group (3,6,15– 17). Four studies comparing RPCA with EA showed that EA is a better analgesic, but maternal satisfaction scores were comparable for both, with no differences in type of delivery or neonatal outcome (6,15–17). These studies had limitations in measurement of maternal satisfaction, which was measured during and/or directly after birth. Waldenstrom (18) found that measurements of satisfaction with childbirth made soon after delivery might be biased. Recently, a large randomized multicenter trial (3) performed in the Netherlands found that both the woman’s satisfaction and the pain relief performance with RPCA was significantly less than with EA. Scores of satisfaction with the pain were limited to the period during labor and directly post labor. All these previous studies focus on pain relief and satisfaction during and directly after birth. No studies have evaluated the overall satisfaction with labor between RPCA and EA at various times after birth. In the Netherlands currently, more than 20 hospitals use RPCA on their labor wards. At one of our institutions, the St. Lucas Andreas Hospital, the clinical experience with RPCA has been good. A short retrospective
Remifentanil versus epidural for labor pain
study prior to the current study was promising, and no side-effects for mother and baby were seen (Frauenfelder S., Radder C. M. & Godfried, M. B., unpublished data). Over the past 3 years, the request for RPCA for delivery has increased at St. Lucas Andreas Hospital. The growing popularity of RPCA and the discrepancy between the higher pain scores was an incentive for us to compare patient satisfaction with EA at three time points after childbirth. In this study, we compared RPCA with EA for labor pain, with the primary outcome being patient satisfaction. The secondary outcome was pain reduction.
Material and methods The Medical Ethical Committee of the St. Lucas Andreas Hospital approved the study protocol (NL17308.029.07). The study design was originally designed as a randomized controlled trial in 2007. We continued to carry out the randomized controlled trial comparing RPCA with EA in healthy primiparous women during active labor for at least 1 year. We were only able to include seven women. More than 100 women refused participation because choice in pain relief is important for women in labor. The question remained whether RPCA could be comparable to EA in terms of a patient’s perception of pain and satisfaction. Based on this, we redesigned the study into a prospective cohort study. St. Lucas Andreas Hospital is one of six obstetric centers (two university centers) in Amsterdam. With 2500 medical deliveries per year, this is a large Dutch obstetric center. In addition, a midwife-led birthing center performs 500 low-risk births a year. Between September 2008 and February 2011, all women with a primary request for analgesia during the first stage of term labor (Figure 1) were asked to participate in our study. The women could choose between RPCA and EA. In the cohort, the selected women were eligible based on the inclusion and exclusion criteria. The inclusion criteria were healthy women with term pregnancies (American Society of Anesthesiologists Physical Status Classification I or II), primiparous women or multiparous women who had never experienced the first stage of labor (primary cesarean delivery), all with uncomplicated singleton pregnancies. Exclusion criteria were women with opiate-related allergies, pethidine (meperidine) intramuscular injection 6 h prior to analgesic request, body mass index >40 kg/ m2 and women with a psychiatric disease history. Women with obstetric conditions such as preeclampsia/eclampsia, HELLP syndrome, severe diabetes, infection/fever and/or placental abnormalities were excluded, as were women with >6 cm cervical dilation. During antenatal care, study information was provided, including a brochure available in different languages. When women had regular contrac-
ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 1014–1021
1015
Remifentanil versus epidural for labor pain
S. Frauenfelder et al.
Inclusion and exclusion criteria
295 patients with labor analgesia request informed consent choice between RPCA and EA
5 patients excluded due to incomplete confirmed consent and/or medical record.
166 patients received RPCA
124 patients received EA
95%), RPCA was terminated immediately. Naloxone 0.4 mg for intravenous administration was present in the delivery rooms at all times. When systolic blood pressure dropped below 100 mmHg, 500 mL of crystalloid was added. If there was no response within 15 min, RPCA was terminated. Fetal conditions were continuously monitored by cardiotocography. If a suboptimal condition was suspected, fetal scalp blood sampling was used to determine fetal pH, base-excess and pCO2. When serious fetal distress was identified, RPCA was terminated, and maternal and fetal conditions were checked. There was a standby emergency team at all times. For women who requested EA, an anesthetist was called. Each woman was connected to default monitoring equipment, i.e. pulse oximeter, blood pressure measurement, three-channel electrocardiogram and cardiotocography, received a peripheral intravenous line (IV), and was asked to sit in an upright position. An 18-gauge Tuohy
Remifentanil versus epidural for labor pain
epidural needle was inserted at lumbar level 2–3, and correct placement was identified by loss of resistance. A 20gauge catheter was then inserted 3–4 cm into the epidural space. After aspiration with a 2-mL syringe for blood or cerebrospinal fluid, a test bolus of 2–3 mL of 0.25% bupivacaine was given. Subsequently, a maximum of 10 mL bupivacaine 0.25% was administered. The epidural catheter was connected to a syringe in a perfusor with a solution of 0.125% bupivacaine with sufentanil 0.2 lg/mL at 6–8 mL/h continuous dose. The epidural infusion was stopped at the start of the second phase of delivery (active “pushing”) or continued if the patient had a good pushing technique and sufficient progress of labor could be achieved. For the primary outcome of general satisfaction with labor and delivery, all women were asked to fill out a translated version of the Woman’s Views of Birth Labour Satisfaction Questionnaire (WOMBLSQ) (19) at the following three time points: within 24 h after delivery (T0), and at 3 months (T3) and 6 months (T6) after birth. The WOMBLSQ is a validated, quantitative, psychometric, multidimensional maternal satisfaction questionnaire containing questions related to 10 dimensions in addition to general satisfaction (19) (see Table S1). The WOMBLSQ consists of 32 questions, numbered consecutively 1–32; women were not aware of the subscales. The questions were statements that required respondents to mark a seven-point Likert scale from “totally disagree” to “totally agree”. A maximum of seven points per question could be scored. There are between two and five questions for every dimension and general satisfaction; thus there are between 14 and 35 total points per subscale or dimension. Within 24 h after birth, women were asked by a midwife to fill in the WOMBLSQ. At 3 and 6 months after birth, the women were sent the WOMBLSQ by post. If they did not return the questionnaire, a telephone call was made to check the address, and a reminder was sent. If there was still no response, the case was defined as lost to follow up. For the secondary outcome of pain reduction during labor analgesia, we assessed pain using the visual analog scale (VAS) before start of drug analgesia and at 5, 30 and 60 min, and at 2 and 8 h after the start of analgesia administration on a scale from 0 to 10. For the safe use of drug analgesia during labor, we assessed the level of sedation using the Ramsay sedation scale at 5, 30 and 60 min, and at 2 and 8 h after the start of the analgesia on a scale from 1 to 4, with level 1 being anxious, agitated and restless; level 2 being co-operative and oriented; level 3 being calm responsive to commands only and level 4 being asleep, brisk response to stimulus. Until the end of RPCA or EA administration, the continuous maternal pulse oximetry and blood pressures were assessed once every 15 min. After delivery, the type of
ª 2015 Nordic Federation of Societies of Obstetrics and Gynecology, Acta Obstetricia et Gynecologica Scandinavica 94 (2015) 1014–1021
1017
Remifentanil versus epidural for labor pain
S. Frauenfelder et al.
Table 1. Baseline characteristics of the study population (primiparous women) requesting labor analgesia. Variable Height (cm)a Weight (kg)a Temperature (C°)a VAS (scale 0–10)a Cervical dilation (cm)b
RPCA (n = 166)
EA (n = 124)
p
166.4 17.8 72.4 14.0 36.9 1.6 8.3 1.6 4 (3–5)
168 7.0 74.0 15.9 36.9 0.5 8.2 1.8 3 (2–4)
0.40 0.29 0.51 0.5
