The RESPITE Trial; offering women greater choice for pain relief in labour
RESPITE; an NIHR funded Randomised Controlled Trial comparing Remifentanil intravenous patient Controlled analgesia (PCA) and intramuscular Pethidine for pain relief in labour recruited at centres across the Midlands and nationwide.
Pethidine is commonly administered in labour despite its effectiveness long being challenged and well known side effects. More than a third of women who receive pethidine subsequently request epidural pain relief. Although highly effective, epidural analgesia increases the risk of a forceps or suction delivery which may extend hospital stay. Whilst this impact is mitigated by modern refinements of epidural technique, it is not prevented.
The availability of Remifentanil patient controlled analgesia in labour is not widespread and its use ordinarily confined to circumstances in which neuraxial analgesia is contraindicated. National adoption as an alternative modality of pain relief is currently haphazard and there is a clear need for high quality evidence to inform decisions on wider implementation
RESPITE recruited women in established labour, requesting systemic opioid pain relief. Participants were randomised to either Remifentanil intravenous PCA or Pethidine intramuscular injection on a 1:1 basis. The primary outcome of RESPITE was the proportion of women who receive epidural pain relief in labour after enrolment, in each group. Secondary outcomes of RESPITE included the effectiveness of pain relief assessed by visual analogue score, maternal side effects and neonatal well-being.
The aim of RESPITE was not to promote the use of Remifentanil but to carefully evaluate it as a "Health Technology" with rigorous trial methodology. The maternal safety profile of the intervention, including sedation indices was closely scrutinised. The study aimed to recruit 400 women in childbirth and on completion will represent a benchmark investigation. The trial was open at 7 UK centres including Birmingham Women’s Hospital, Royal Stoke University Hospital (UHNM) and New Cross Hospital, Wolverhampton. We are open to enrol new centres interested in participation. As a study adopted to the UKCRN National Portfolio, RESPITE automatically qualifies recruiting centres for local Trust infrastructure support via Clinical Research Facilities.
If you would like more information please contact the trial team at [email protected] or view the end of trial report here.
The publication detailing the results can be found here and there is also information on the Birmingham University website here.
The Chief Investigator for RESPITE was Dr Matt Wilson, Senior Lecturer in Anaesthesia, University of Sheffield. The trial is being sponsored by University of Birmingham with trial coordination and administration being provided by Birmingham Clinical Trials Unit.
RESPITE; an NIHR funded Randomised Controlled Trial comparing Remifentanil intravenous patient Controlled analgesia (PCA) and intramuscular Pethidine for pain relief in labour recruited at centres across the Midlands and nationwide.
Pethidine is commonly administered in labour despite its effectiveness long being challenged and well known side effects. More than a third of women who receive pethidine subsequently request epidural pain relief. Although highly effective, epidural analgesia increases the risk of a forceps or suction delivery which may extend hospital stay. Whilst this impact is mitigated by modern refinements of epidural technique, it is not prevented.
The availability of Remifentanil patient controlled analgesia in labour is not widespread and its use ordinarily confined to circumstances in which neuraxial analgesia is contraindicated. National adoption as an alternative modality of pain relief is currently haphazard and there is a clear need for high quality evidence to inform decisions on wider implementation
RESPITE recruited women in established labour, requesting systemic opioid pain relief. Participants were randomised to either Remifentanil intravenous PCA or Pethidine intramuscular injection on a 1:1 basis. The primary outcome of RESPITE was the proportion of women who receive epidural pain relief in labour after enrolment, in each group. Secondary outcomes of RESPITE included the effectiveness of pain relief assessed by visual analogue score, maternal side effects and neonatal well-being.
The aim of RESPITE was not to promote the use of Remifentanil but to carefully evaluate it as a "Health Technology" with rigorous trial methodology. The maternal safety profile of the intervention, including sedation indices was closely scrutinised. The study aimed to recruit 400 women in childbirth and on completion will represent a benchmark investigation. The trial was open at 7 UK centres including Birmingham Women’s Hospital, Royal Stoke University Hospital (UHNM) and New Cross Hospital, Wolverhampton. We are open to enrol new centres interested in participation. As a study adopted to the UKCRN National Portfolio, RESPITE automatically qualifies recruiting centres for local Trust infrastructure support via Clinical Research Facilities.
If you would like more information please contact the trial team at [email protected] or view the end of trial report here.
The publication detailing the results can be found here and there is also information on the Birmingham University website here.
The Chief Investigator for RESPITE was Dr Matt Wilson, Senior Lecturer in Anaesthesia, University of Sheffield. The trial is being sponsored by University of Birmingham with trial coordination and administration being provided by Birmingham Clinical Trials Unit.