Patient‐controlled analgesia with remifentanil versus alternative parenteral methods for pain management in labour
Appendices
Appendix 1. ClinicalTrials.gov and ICTRP search strategy
remifentanil AND labor
remifentanil AND labour
Appendix 2. Study eligibility form
| Author (Year) | ||
| Title | ||
| Journal | ||
| Name of review author | ||
| Identified through | Main search/references/additional searches. | |
| Relevant study design | Randomised controlled trial. | Yes/No/Unclear |
| Relevant population | Women in labour with planned vaginal delivery including women of high‐risk groups. Specifically excluded are women undergoing caesarean section. | Yes/No/Unclear |
| Relevant intervention | Experimental group must have received remifentanil administered via a patient‐controlled analgesia device for pain relief in labour. No other analgesics are allowed for simultaneous administration. Control group must have placebo treatment, no treatment, or any other intervention for pain relief in labour. | Yes/No/Unclear |
| Intervention experimental | ||
| Intervention control | ||
| If you have not answered Yes to all of the questions, please exclude the study. If you answered Yes to all questions, please continue to data extraction form and critical appraisal. | ||
Appendix 3. Data extraction form
| Author (Year) |
| |
| Title |
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| Journal/Source |
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| Objectives | ||
| Study registration (registry number, date) |
| |
| Study protocol (date published) | ||
| Funding | ||
| Study design/Methods | RCT, blinding, randomisation | |
| Approval and written informed consent | ||
| Inclusion criteria | ||
| Exclusion criteria | ||
| Sample size calculation reported (outcome, n) | ||
| Participant flow | ||
| Number of participants assessed for eligibility | ||
| Experimental | Control | |
| Number of participants randomised | ||
| Number of participants receiving treatment | ||
| Number of participants analysed | ||
| Population/Baseline details | Experimental | Control |
| Mean age/Median age |
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| Mean weight/Median weight |
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| Type of delivery (spontaneous delivery, induced labour, preterm labour, etc.) |
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| Week of gestation |
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| Singleton, twin , multiple pregnancy |
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| Number of birth |
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| Duration of labour |
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| Notes | ||
| Intervention | |
| Length of remifentanil infusion (if stated) | |
| Dose of remifentanil infusion | |
| Total administered dose of remifentanil infusion (if stated) | |
| Starting point of administration before delivery (if stated) | |
| Ending point of administration after delivery (if stated) | |
| Type of control intervention |
| Dichotomous outcome data | Experimental | Control | ||
| (n) Number assessed | (n) Number with outcome | (n) Number assessed | (n) Number with outcome | |
| Additional analgesia required (e.g. conversion to epidural analgesia) | ||||
| Conversion to caesarean delivery | ||||
| Breastfeeding initiation | ||||
| Assisted vaginal birth | ||||
| Need for neonatal resuscitation | ||||
| Adverse events for women (e.g. apnoea, respiratory depression, oxygen desaturation, hypotension, bradycardia, nausea, vomiting, postpartum haemorrhage, maternal somnolence) | ||||
| Adverse events for the newborn (e.g. APGAR scores less than seven at five minutes, need for naloxone, depressed baby, opioid‐induced loss of fetal heart rate variability) | ||||
| Continuous outcome data | Experimental | Control | ||
| n | Mean (SD) | n | Mean (SD) | |
| Satisfaction with pain relief |
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| Sense of control in labour | ||||
| Effect (negative) on mother/baby interaction |
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| Pain scores |
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| Satisfaction with childbirth experience |
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| Long‐term childhood development |
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| Cost | ||||
| Umbilical cord base excess (arterial) | ||||
| Umbilical cord base excess (venous) | ||||
| Umbilical cord pH (arterial) | ||||
| Umbilical cord pH (venous) | ||||
Appendix 4. Critical appraisal form
| Author (Year) |
| |
| Journal |
| |
| Title |
| |
| Random sequence generation (selection bias) | ||
| State here the method used to generate allocation and reasons for grading | Adequate/Inadequate/Unclear | |
| Allocation concealment (selection bias) | ||
| State here the method used to conceal allocation and reasons for grading | Adequate/Inadequate/Unclear | |
| Blinding of participants and personnel (performance bias) | ||
| Person responsible for participants care | Low risk/High risk/Unclear | |
| Participant | Low risk/High risk/Unclear | |
| Blinding of outcome assessment (detection bias) | ||
| Outcome assessor | Low risk/High risk/Unclear | |
| Incomplete outcome data (attrition bias) | ||
| All participants entering trial | Yes/No/Unclear | |
| 15% or fewer excluded | Yes/No/Unclear | |
| More than 15% excluded | Yes/No/Unclear | |
| Analysed as intention‐to‐treat | Yes/No/Unclear | |
| Were withdrawals described? | Low risk/High risk/Unclear | |
| Selective reporting (reporting bias) | ||
| Free of selective outcome reporting? | Yes/No/Unclear | |
| Other bias | ||
| Other sources of bias | Yes/No/Unclear | |
