Pain Relief in Labour Clinical Trial
— RESPITEOfficial title:
A Randomised Controlled Trial of Remifentanil Intravenous Patient Controlled Analgesia (PCA) Versus Intramuscular Pethidine for Pain Relief in Labour
| Verified date | October 2018 |
| Source | University of Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Childbirth can be an extremely painful and the provision of pain relief during labour is a vital component of a positive maternal experience. The majority of women who deliver in modern obstetric units choose a pharmacological method of pain relief, including Entonox, the injection of opioids or epidural placement. The commonest opioid used in labour is pethidine administered by intramuscular (im) injection. The effectiveness of pain relief provided by pethidine has long been challenged. Its shortcomings are more serious when set against known side effects including maternal sedation, nausea and potential transfer across the placenta to the foetus. More than a third of women who receive pethidine subsequently require an epidural due to inadequate pain relief. Epidurals provide highly effective pain relief, but increase the risk of a forceps or suction delivery resulting in prolonged hospital stay. Therefore, there is a clear need for a safe, effective, easy to administer analgesic alternative.
| Status | Completed |
| Enrollment | 401 |
| Est. completion date | September 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: Women who are admitted to labour ward who fulfil all the following criteria will be eligible to be randomised: - Requesting systemic opioid analgesia - 16 years of age or older - Beyond 37 weeks gestation - In established labour, defined as regular painful contractions, irrespective of cervical dilatation, with vaginal birth intended - Able to understand all information (written and oral) presented (using an interpreter if necessary) - Not participating in any other clinical trial of a medicinal product - Live, singleton pregnancy with cephalic presentation Exclusion Criteria: - Contraindication to epidural analgesia - Contraindication to intramuscular injection - History of a previous adverse reaction to pethidine or remifentanil - Patients taking long term opioid therapy including Methadone - Systemic pain relief opioid in the last 4 hours administered by intravenous or intramuscular injection. (Oral medications comprising opioids alone or in combination preparations, administered in this 4 hour period, are permitted). |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Birmingham Clinical Trials Unit | Birmingham | West Midlands |
| Lead Sponsor | Collaborator |
|---|---|
| University of Birmingham | Birmingham Women's NHS Foundation Trust, Bradford Royal Infirmary, City Hospital Birmingham, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK), Frimley Park Hospital, Good Hope Hospital, Heartlands Hospital, Homerton University Hospital, Medway Maritime Hospital, Northwick Park Hospital, Stoke Mandeville Hospital, University Hospital Coventry, University Hospital of North Midlands, Warwick Hospital, York Hospital |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of women who receive epidural analgesia for pain relief in labour, in each group, after randomisation. | The proportion of women who receive epidural analgesia for pain relief in labour, in each group, after randomization. | At labour | |
| Secondary | • The effectiveness of pain relief provided by each technique, quantified by Visual Analogue Scale | • The effectiveness of pain relief provided by each technique, quantified by Visual Analogue Scale | Post natally - Average of 2-3days after delivery | |
| Secondary | The incidence of maternal side effects | The incidence of maternal side effects including Excessive sedation score Oxygen Saturation <94% whilst breathing room air Nausea requiring anti-emetic administration Requirement and indication for supplemental oxygen Respiratory Depression (Respiratory rate < 8 breaths/minute) |
Post Natally - Average of 2-3days after delivery | |
| Secondary | Delivery mode (Spontaneous, Instrumental Vaginal, Caesarean Section) | Delivery mode (Spontaneous, Instrumental Vaginal, Caesarean Section) | Post Natally - Average of 2-3days after delivery | |
| Secondary | Incidence of foetal distress requiring delivery | Incidence of foetal distress requiring delivery | Post Natally - Average of 2-3days after delivery | |
| Secondary | Neonatal status at delivery | Neonatal status at delivery: Apgar score at 5 minutes Incidence of foetal acidosis determined by umbilical cord gas analysis Requirement for neonatal resuscitation Incidence of and indication for admission to neonatal care |
Post Natally - Average of 2-3days after delivery | |
| Secondary | Rate of initiation of breast feeding within the first hour of birth | Rate of initiation of breast feeding within the first hour of birth | Post Natally - 1 hour after delivery | |
| Secondary | Maternal satisfaction with childbirth experience determined by postpartum questionnaire prior to discharge from the delivery ward | Maternal satisfaction with childbirth experience determined by postpartum questionnaire prior to discharge from the delivery ward | Post Natally - Average of 2-3days after delivery | |
| Secondary | Maternal birth experience determined by qualitative telephone interview up to six weeks postpartum | Explore and compare women's birth experiences up to six weeks postpartum via qualitative telephone interview (Post-Natal sub-study) | Up to 6 weeks post-partum | |
| Secondary | Maternal perceptions of pain relief determined by qualitative telephone interview up to six weeks postpartum | Explore and compare women's perceptions of pain relief up to six weeks postpartum via qualitative telephone interview (Post-Natal sub-study) | Up to 6 weeks post-partum | |
| Secondary | Infant feeding behaviours determined by qualitative telephone interview up to six weeks postpartum | Explore and compare infant feeding behaviours up to six weeks postpartum via qualitative telephone interview (Post-Natal sub-study) | Up to 6 weeks post-partum |