Patient-controlled analgesia with remifentanil versus alternative parenteral methods for pain management in labour.
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SUBMITTER: Weibel S
PROVIDER: S-EPMC6478102 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:OBJECTIVE:To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN:Multicentre randomised controlled equivalence trial. SETTING:15 hospitals in the Netherlands. PARTICIPANTS:Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data. INTERVENTION:Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour. MAIN OUTCOME MEASURES:Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome. RESULTS:1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group (mean difference -2.8, 95% confidence interval -6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference -10.4, -13.9 to -7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups. CONCLUSION:In women in labour, 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. TRIAL REGISTRATION:Netherlands Trial Register NTR2551.
| S-EPMC4353278 | biostudies-literature
Project description:ObjectivesTo explore women's experiences of remifentanil or pethidine for labour pain and infant feeding behaviours at 6weeks post partum.DesignQualitative postnatal sub-study to the randomised controlled trial of remifentanil intravenous patient controlled analgesia (PCA) versus intramuscular pethidine for pain relief in labour (RESPITE). Semistructured telephone interviews were conducted at 6 weeks post partum, and thematic analysis was undertaken.SettingWomen recruited to the RESPITE trial from seven UK hospitals.ParticipantsEighty women consented and 49 (30 remifentanil group and 19 pethidine group) completed the interview.ResultsEight themes emerged which encompassed women's antenatal plans for pain management (Birth Expectations) through to their future preferences for pain relief (Reflections for Future Choices). Many women who used remifentanil felt it provided effective pain relief (Effectiveness of Pain Relief), whereas women in the pethidine group expressed more mixed views. Both groups described side effects, with women using pethidine frequently reporting nausea (Negative Physiological Responses) and women using remifentanil describing more cognitive effects (Cognitive Effects). Some women who used remifentanil reported restricted movements due to technical aspects of drug administration and fear of analgesia running out (Issues with Drug Administration). Women described how remifentanil enabled them to maintain their ability to stay focused during the birth (Enabling a Sense of Control). There was little difference in reported breastfeeding initiation and continuation between pethidine and remifentanil groups (Impact on Infant Behaviour and Breastfeeding).ConclusionsQualitative insights from a follow-up study to a trial which explored experiences of intravenous remifentanil PCA with intramuscular pethidine injection found that remifentanil appeared to provide effective pain relief while allowing women to remain alert and focused during labour, although as with pethidine, some side effects were noted. Overall, there was little difference in reported breastfeeding initiation and duration between the two groups.Trial registration numberISRCTN29654603.
| S-EPMC7008414 | biostudies-literature
Project description: Not available
| S-EPMC6513033 | biostudies-literature
Project description:ObjectiveTo compare the costs of a strategy of patient controlled remifentanil versus epidural analgesia for pain relief in labour.DesignWe performed a multicentre randomised controlled trial in 15 hospitals in the Netherlands, the RAVEL trial. Costs were analysed from a health care perspective alongside the RAVEL trial.PopulationPregnant women of intermediate to high risk beyond 32 weeks gestation who planned vaginal delivery.MethodsWomen were randomised before the onset of labour, to receive either patient controlled remifentanil or epidural analgesia when pain relief was requested during labour.Main outcome measuresPrimary outcome for effectiveness was satisfaction with pain relief, expressed as the area under the curve (AUC). A higher AUC represents higher satisfaction with pain relief. Here, we present an economic analysis from a health care perspective including costs from the start of labour to ten days postpartum. Health-care utilization was documented in the Case Report Forms and by administering an additional questionnaire.ResultsThe costs in the patient controlled remifentanil group (n = 687) and in the epidural group (n = 671) were €2900 versus €3185 respectively (mean difference of -€282 (95% CI -€611 to €47)). The (non-significant) higher costs in the epidural analgesia group could be mainly attributed to higher costs of neonatal admission.ConclusionFrom an economic perspective, there is no preferential pain treatment in labouring intermediate to high risk women. Since patient controlled remifentanil is not equivalent to epidural analgesia with respect to AUC for satisfaction with pain relief we recommend epidural analgesia as the method of choice. However, if appropriately counselled on effect and side effects there is, from an economic perspective, no reason to deny women patient controlled remifentanil.
| S-EPMC6181333 | biostudies-literature
Project description:BACKGROUND:This is an updated version of the original Cochrane review published in Issue 4, 2006. Patients may control postoperative pain by self administration of intravenous opioids using devices designed for this purpose (patient controlled analgesia or PCA). A 1992 meta-analysis by Ballantyne et al found a strong patient preference for PCA over non-patient controlled analgesia, but disclosed no differences in analgesic consumption or length of postoperative hospital stay. Although Ballantyne's meta-analysis found that PCA did have a small but statistically significant benefit upon pain intensity, a 2001 review by Walder et al did not find statistically significant differences in pain intensity or pain relief between PCA and groups treated with non-patient controlled analgesia. OBJECTIVES:To evaluate the efficacy and safety of patient controlled intravenous opioid analgesia (termed PCA in this review) versus non-patient controlled opioid analgesia of as-needed opioid analgesia for postoperative pain relief. SEARCH METHODS:We ran the search for the previous review in November 2004. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 12), MEDLINE (1966 to 28 January 2015), and EMBASE (1980 to 28 January 2015) for randomized controlled trials (RCTs) in any language, and reference lists of reviews and retrieved articles. SELECTION CRITERIA:We selected RCTs that assessed pain intensity as a primary or secondary outcome. These studies compared PCA without a continuous background infusion with non-patient controlled opioid analgesic regimens. We excluded studies that explicitly stated they involved patients with chronic pain. DATA COLLECTION AND ANALYSIS:Two review authors independently extracted data, which included demographic variables, type of surgery, interventions, efficacy, and adverse events. We graded each included study for methodological quality by assessing risk of bias and employed the GRADE approach to assess the overall quality of the evidence. We performed meta-analysis of outcomes that included pain intensity assessed by a 0 to 100 visual analog scale (VAS), opioid consumption, patient satisfaction, length of stay, and adverse events. MAIN RESULTS:Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group met the inclusion criteria. The original review included 55 studies with 2023 patients receiving PCA and 1838 patients assigned to a control group. There were fewer included studies in our updated review due to the revised exclusion criteria. For the primary outcome, participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals, e.g., scores over 0 to 24 hours were nine points lower (95% confidence interval (CI) -13 to -5, moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12 to -7, low quality evidence). Among the secondary outcomes, participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (0 to 24 hours, 7 mg more of intravenous morphine equivalents, 95% CI 1 mg to 13 mg). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay. AUTHORS' CONCLUSIONS:Since the last version of this review, we have found new studies providing additional information. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides moderate to low quality evidence that PCA is an efficacious alternative to non-patient controlled systemic analgesia for postoperative pain control.
| S-EPMC7387354 | biostudies-literature
Project description:BACKGROUND:Intravenous remifentanil patient-controlled analgesia (RPCA) is an alternative for epidural analgesia (EA) in labor pain relief. However, it remains unknown whether RPCA is superior to EA in decreasing the risk of intrapartum maternal fever during labor. METHODS:According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic review and meta-analysis was performed by searching PubMed, EMBASE and the Cochrane Central Register of Controlled Trials from inception to April 2019. All randomized controlled trials (RCTs) investigating the risk of intrapartum maternal fever with RPCA compared with EA alone or EA in combination with spinal analgesia during labor were included. RESULTS:A total of 825 studies were screened, and 6 RCTs including 3341 patients were identified. Compared with EA, RPCA was associated with a significantly lower incidence of intrapartum maternal fever (risk ratio [RR] 0.48, P?=?0.02, I2?=?49%) during labor analgesia. After excluding 2 trials via the heterogeneity analysis, there was no difference in the incidence of intrapartum fever between patients receiving RPCA and those receiving EA. Satisfaction with pain relief during labor was lower in the RPCA group than that in the EA group (-?10.6 [13.87, -?7.44], P?<?0.00001, I2?=?0%). The incidence of respiratory depression was significantly greater in the RPCA group than that in the EA group (risk ratio 2.86 [1.65, 4.96], P?=?0.0002, I2?=?58%). The incidence of Apgar scores <?7 at 5?min in the RPCA group was equivalent to that in the EA group. CONCLUSION:There is no solid evidence to illustrate that the incidence of intrapartum maternal fever is lower in patients receiving intravenous RPCA than in patients receiving EA.
| S-EPMC7069013 | biostudies-literature
Project description:BACKGROUND: Pain management after cardiac surgery has been based on parenteral long-acting opioids such as morphine. The other alternatives are paracetamol and remifentanil. OBJECTIVES: In this prospective, double-blind, randomized study, we compared the efficacy of intravenous patient-controlled analgesia (IV-PCA) paracetamol and remifentanil for post cardiac surgery pain relief. MATERIALS AND METHODS: One-hundred patients scheduled for elective coronary artery bypass grafting from May to October 2011, were randomized into two groups after the surgery. For the first group (group R, n = 50, with mean age of 58.16 ± 11.80), the IV-PCA protocol was remifentanil infusion 100 μg/h; bolus of 25 μg and lockout time of 15 minutes. In the second group (group P, n = 50, with mean age of 53.8 ± 15.08), patients received paracetamol 15 mg/kg as a bolus at the end of surgery and then IV-PCA protocol was 100 μg/h, bolus of 25 μg; and lockout time of 15 minutes. Pain was assessed with visual analog scale score (VAS) in the first 24 hours after surgery for seven times. RESULTS: The trend of pain scores did not have any significantly difference between group R and group P except for hour 8 and hour 18 after surgery that VAS was significantly lower in group P than group R (P = 0.031, P = 0.023, respectively). Respiratory rate (RR) was also statistically lower in group R comparing to group P in all seven evaluating times. The groups were similar in terms of hemodynamic, ABG results (except for PaO2, which was significantly lower in group R than group P at 6 evaluating times), intubation time, renal function tests, and incidences of atelectasis, myocardial infarction or adverse effects. CONCLUSIONS: Both PCA techniques provided effective pain scores (< 3) after cardiac surgery; but generally, PCA-paracetamol infusion has a better analgesic effect.
| S-EPMC4333302 | biostudies-other
Project description:BACKGROUND AND OBJECTIVES:This study aimed to (1) identify patient-controlled analgesia (PCA) attributes that negatively impact patient satisfaction and ability to control pain while using PCA and (2) obtain data on patient perceptions of new PCA design features. METHODS:We conducted a prospective survey study of postoperative pain control among patients using a PCA device. The survey was designed to evaluate patient satisfaction with pain control, understanding of PCA, difficulties using PCA, lockout-period management, and evaluation of new PCA design features. RESULTS:A total of 350 eligible patients completed the survey (91%). Patients who had difficulties using PCA were less satisfied (P < 0.001) and were more likely to feel unable to control their pain (P < 0.001). Satisfaction and self-reported ability to control pain were not affected by patient education about the PCA. Forty-nine percent of patients reported not knowing if they would receive medicine when they pushed the PCA button, and of these, 22% believed that this uncertainty made their pain worse. The majority of patients preferred the proposed PCA design features for easier use, including a light on the button, making it easier to find (57%), and a PCA button that vibrates (55%) or lights up (70%), alerting the patient that the PCA pump is able to deliver more medicine. CONCLUSIONS:A majority of patients, irrespective of their satisfaction with PCA, preferred a new PCA design. Certain attributes of current PCA technology may negatively impact patient experience, and modifications could potentially address these concerns and improve patient outcomes.
| S-EPMC3717314 | biostudies-literature
Project description: Not available
| S-EPMC6494625 | biostudies-literature
Project description:BackgroundLabour pain has been identified as an important reason for women to prefer caesarean section (CS). Fentanyl is one of the short acting opioids recommended by World Health Organization for pain relief during labour. This study aimed to identify and describe the available evidence on the use of fentanyl (monotherapy) for labour pain management by any routes of administration or regime.MethodsWe included the records published until 31 December 2021 which reported administration of fentanyl to women with normal labour for labour pain relief. Data were extracted by one reviewer and checked by another reviewer using a standardised agreement form. We mapped and presented data descriptively in figure and tabular format.ResultsWe included 51 records from 49 studies in our scoping review. The studies were conducted in 12 countries, mostly high-income countries. The study designs of the 51 included records were varied as follows: 38 (74.5%) experimental studies (35 randomised controlled trials and three quasi-experimental studies), and 12 (23.5%) observational studies (five retrospective cohort studies, four prospective cohort studies, two retrospective descriptive studies, and one descriptive study) and one qualitative study. Of the included records, six used intranasal fentanyl, five used subcutaneous fentanyl, 18 (35.3%) used intravenous fentanyl, 18 (35.3%) used intrathecal fentanyl, and nine used epidural fentanyl. Many records compared fentanyl with another analgesic agent while five records (9.8%) had no comparison group and seven records (13.7%) compared with no analgesia group. The doses of fentanyl varied by routes, study and the requirement depended on the women. Pain assessment was the most frequent outcome measure presented in the records (78.4%). Only nine records (17.6%) investigated women's satisfaction about labour pain relief using fentanyl and seven records (13.7%) reported the effect of fentanyl on breastfeeding. The most common reported neonatal outcomes were foetal heart rate (33 records, 64.7%) and Apgar score (32 records, 62.7%).ConclusionThere is limited primary evidence especially randomised controlled trials to evaluate the effectiveness and harms of different routes of fentanyl in low- or middle-income countries. There is a need for high-quality research to establish the most effective route of fentanyl and associated effects for evidence-based international guidelines.
| S-EPMC9670642 | biostudies-literature