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Obstetric analgesia: a comparison of patient controlled Pethidine, Remifentanil and Fentanyl in labour.


- candidate number1878
- NTR NumberNTR543
- ISRCTNISRCTN12122492
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR4-dec-2005
- Secondary IDsN/A 
- Public TitleObstetric analgesia: a comparison of patient controlled Pethidine, Remifentanil and Fentanyl in labour.
- Scientific TitleObstetric analgesia: a comparison of patient controlled pethidine, remifentanil and fentanyl in labour.
- ACRONYMbaringspijn
- hypothesisThe hypothesis of this study is that the new opioid remifentanil will provide less side-effects and better painrelief during labour, than the conventional opioids fentanyl and pethidine.
- Healt Condition(s) or Problem(s) studiedLabour pain
- Inclusion criteria1. Age: at least 18 years old;
2. Between 37 and 42 weeks of gestation;
3. ASA physical status I or II.
- Exclusion criteria1. ASA physical status >= III;
2. Obesity (BMI equal or more than 40 kg/m2);
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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-aug-2005
- planned closingdate1-sep-2006
- Target number of participants180
- InterventionsThe following drugs are used in a patient controlled method:
1. Pethidine;
2. Remifentanil;
3. Fentanyl.
Medication will be started in active labour en will be continued untill complete dilation of the cervix is achieved.
- Primary outcome1. Quality of pain relief determined by Visual Analogue Scale, PCA demands/rewards and the number of parturients crossing over to epidural analgesia;
2. Patient satisfaction;
3. Fetal Outcome as determined by Apgar, NACS and requirement for naloxone;
4. Presence of opioid substances in umbilical and maternal blood samples.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. M.R. Douma
- CONTACT for SCIENTIFIC QUERIESDrs. M.R. Douma
- Sponsor/Initiator Bronovo Hospital, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Reseachfonds Bronovo, Bronovo Hospital, The Hague
- PublicationsN/A
- Brief summaryObstetric analgesia: A comparison of patient controlled pethidine, remifentanil and fentanyl in labour.


Background:
There is great need for new analgesic methods during labour. The purpose of this study is to compare a relatively new agent, remifentanil, with two conventional analgesics, pethidine and fentanyl.
Remifentanil is characterized by a rapid onset of action and short latency to its peak effect. The elimination half-time ranges from 8 to 20 minutes. There is no accumulation of the drug during repeat bolus injection. These characteristics make remifentanil very suitable for administration via patient controlled analgesia (PCA), which can be used for analgesia during labour.


Objective:
The main objective of this study is to compare the analgesic efficacy and safety of remifentanil, pethidine and fentanyl during labour, when all are administered as patient-controlled analgesia.


Outcome parameters are:
1. Quality of pain relief as determined by Visual Analogue Scale, PCA demands/rewards and number of parturients crossing over to epidural analgesia;
2. Patient Satisfaction;
3. Fetal Outcome as determined by Apgar, NACS and requirement for naloxone;
4. Presence of opioid substances in umbilical cord and maternal blood samples.


Study design:
This study will be a double-blind randomized controlled clinical trial and will evaluate three different analgesic drugs during labour. All drugs will be administered using a PCA device.


Population:
Women in an early, but active stage of labour (with minimum dilation cervical of 3 cm), who make a request for analgesia. The planned sample size is around 240 patients.


Drugs/dosages:
The following drugs are used in a patient controlled method:
Drug Loading Dose Dosage/bolus Lockout timeMax. Total Dosage Remifentanil - 40 ėg 2 min. 1200 ėg/h Pethidine 50 mg 5 mg 10 min. 200 mg Fentanyl 50 ėg 20 ėg 5 min. 240 ėg/h

Load on patient and risks involved with the research.
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 min. Fetal heart rate and uterine activity will be recorded by external monitoring. Pain scores will be assessed every hour using a visual analogue scale. Satifaction scores, sedation scores and anxiety scores will be assessed in the same way. These scores will also be recorded hourly. After delivery, there will be taken a maternal and an umbilical cord blood sample in order to determine opioid serum concentration.
All opioids have similar side effects. Most important in this research is the possibility of respiratory depression. In order to monitor the occurrence of side effects and reduce risks to the patient the progress will continuously be monitored by the medical students executing the research protocol (in collaboration with attending gynaecologist).
- Main changes (audit trail)
- RECORD4-dec-2005 - 3-feb-2009


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