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Patient‐controlled analgesia with remifentanil versus alternative parenteral methods for pain management in labour

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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

 

Journal/Source

 

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

 

 

Mean weight/Median weight

 

 

Type of delivery (spontaneous delivery, induced labour, preterm labour, etc.)

 

 

Week of gestation

 

 

Singleton, twin , multiple pregnancy

 

 

Number of birth

 

 

Duration of labour

 

 

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
(Unit of measurement)

Experimental

Control

n

Mean (SD)

n

Mean (SD)

Satisfaction with pain relief

 

 

 

 

Sense of control in labour

Effect (negative) on mother/baby interaction

 

 

 

 

Pain scores

 

 

 

 

Satisfaction with childbirth experience

 

 

 

 

Long‐term childhood development

 

 

 

 

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