Obstetric analgesia: a comparison of patient controlled pethidine, remifentanil and fentanyl in labour

ISRCTN	ISRCTN12122492
DOI	https://doi.org/10.1186/ISRCTN12122492
Protocol serial number	NTR543
Sponsor	Bronovo Hospital (The Netherlands)
Funder	Bronovo Hospital (The Netherlands) - research funds

Submission date: 14/02/2006
Registration date: 14/02/2006
Last edited: 04/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M R Douma
Scientific

Bronovo Hospital
Department of Obstetrics and Gynaecology
Bronovolaan 5
The Hague
2597 AX
Netherlands

Phone	+31 (0)61 427 6591
Email	maritdouma@hotmail.com

Study information

Primary study design	Interventional
Study design	Double-blind randomised active controlled parallel group clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Baringspijn
Study objectives	The hypothesis of this study is that the new opioid remifentanil will provide less side-effects and better pain relief during labour, than the conventional opioids fentanyl and pethidine.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Labour pain
Intervention	The following drugs are used in a patient controlled method: 1. Remifentanil - 40 µg for 2 minutes, total dosage: 1200 µg/h 2. Pethidine - loading dose of 50 mg, then 5 mg for 10 minutes, total dosage: 200 mg 3. Fentanyl - loading dose of 50 µg, then 20 µg for 5 minutes, total dosage: 240 µg/h Medication will be started in active labour and will be continued until complete dilation of the cervix is achieved. Baseline non-invasive measurements will be made, including maternal blood pressure, heart rate, respiratory rate and pulse oximetry. Measurements will be recorded every 30 minutes. Also, an observer sedation score will be recorded every 30 minutes.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Pethidine, remifentanil, fentanyl
Primary outcome measure(s)	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. 2. Patient satisfaction, assessed every hour 3. Foetal outcome as determined by Apgar, NACS and requirement for naloxone, taken after delivery 4. Presence of opioid substances in umbilical and maternal blood samples, taken after delivery
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	240
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	10/08/2005
Date of final enrolment	01/09/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Bronovo Hospital

The Hague
2597 AX
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan