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document
The IDvIP trial : a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia . BACKGROUND Intramuscular pethidine is routinely used throughout the UK for labour analgesia . Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate . It can cause nausea , vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations . Neonatal effects include respiratory depression and impaired feeding . There are few large studies comparing the relative side effects and efficacy of different opioids in labour . A small trial comparing intramuscular pethidine with diamorphine , showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid . METHODS The Intramuscular Diamorphine versus Intramuscular Pethidine ( IDvIP ) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother , fetus and neonate . Information about the trial will be provided to women in the antenatal period or in early labour . Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia . The sample size requirement is 406 women with data on primary outcomes . The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes . The neonatal primary outcomes are need for resuscitation and Apgar Score < 7 at 1 minute . The secondary outcomes are an additional measure of pain relief , maternal sedation , nausea and vomiting , maternal oxygen saturation , satisfaction with analgesia , whether method of analgesia would be used again , use of Entonox , umbilical arterial and venous pH , fetal heart rate , meconium staining , time from delivery to first breath , Apgar scores at 5 mins , naloxone requirement , transfer to neonatal intensive care unit , neonatal haemoglobin oxygen saturation at 30 , 60 , 90 , and 120 mins after delivery , and neonatal sedation and feeding behaviour during first 2 hours . DISCUSSION If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour . TRIAL REGISTRATION ISRCTN14898678Eudra No : 2006-003250-18 , REC Reference No : 06/Q1702/95 , MHRA Authorisation No : 1443/0001/001-0001 , NIHR UKCRN reference 6895 , RfPB grant PB-PG-0407-13170_IR5 .
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Intervention_Pharmacological
diamorphine
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Intervention_Pharmacological
pethidine
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Intervention_Pharmacological
pethidine
50940
Intervention_Pharmacological
pethidine
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Intervention_Pharmacological
pethidine
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Intervention_Pharmacological
diamorphine
50943
Intervention_Pharmacological
diamorphine
50944
Intervention_Pharmacological
pethidine
50945
Intervention_Pharmacological
Diamorphine
50946
Intervention_Pharmacological
Pethidine
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Intervention_Pharmacological
diamorphine
50948
Intervention_Pharmacological
pethidine
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Intervention_Pharmacological
diamorphine
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Intervention_Pharmacological
diamorphine
50951
Intervention_Pharmacological
opioid
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Outcome_Pain
pain relief during the first 3 hours after trial analgesia
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Outcome_Pain
pain relief after 60 minutes .
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Outcome_Physical
need for resuscitation and Apgar Score < 7 at 1 minute .
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Participant_Condition
406 women with data on primary outcomes .