Obstetric analgesia: a comparison of patient controlled pethidine, remifentanil and fentanyl in labour
- Conditions
- abour painPregnancy and ChildbirthLabour
- Registration Number
- ISRCTN12122492
- Lead Sponsor
- Bronovo Hospital (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
1. Aged at least 18 years old
2. Between 37 and 42 weeks of gestation
3. American Society of Anaesthesiologists (ASA) physical status I or II
1. ASA physical status greater than or equal to III
2. Obesity (body mass index [BMI] equal or more than 40 kg/m^2)
3. Substance abuse history
4. High risk patients: including pre-eclampsia (diastolic pressure equal or more than 100, proteinuria), hepatic insufficiency or renal failure, severe asthma, poorly controlled diabetes mellitus
5. Premature labour
6. Drug allergy; history of hypersensitivity to opioid substances
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Quality of pain relief determined by Visual Analogue Scale, patient controlled analgesia (PCA) demands/rewards and the number of patients crossing over to epidural analgesia. Pain scores will be assessed every hour. <br>2. Patient satisfaction, assessed every hour<br>3. Foetal outcome as determined by Apgar, NACS and requirement for naloxone, taken after delivery<br>4. Presence of opioid substances in umbilical and maternal blood samples, taken after delivery
- Secondary Outcome Measures
Name Time Method o secondary outcome measures