The PaPa Trial: Paracetamol as an adjunct to intraPartum Remifentanil/PCA. An RCT of multimodal pain management during labor.
- Conditions
- abour pain
- Registration Number
- NL-OMON24756
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Pregnant, in labour, >3 centimetres dilatation.
•Pain request during labour, medication of choice: Remifentanil/ PCA.
•Age 18 years and older.
•Able to understand the written and verbal information about the PaPa Trial.
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Refusal for participation in the PaPa Trial
•No adequate communication possible (e.g. language barrier)
•Use of other opioids, e.g. Pethidine of epidural analgesia <4 hours prior to start of Remifentanil as pain management.
•Hypersensitivity for Paracetamol.
•Liver- of kidneydiseases
•Alcohol abuse
•Glucose-6-phosphate dehydrogenase
•Use of other medication that contains Paracetamol
•Severe nutritional deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remifentanil bolus requests and actual administered Remifentanil doses at 30, 60, 90, 120, 150, 180 minutes from zerotime: start of treatment with Remifentanil and either Paracetamol IV or Placebo.
- Secondary Outcome Measures
Name Time Method Maternal parameters: Need for oxygen administration, frequency of vomiting, time to full dilatation in minutes from start of pain treatment, <br>Neonatal parameters: Apgar Score=7 after 5 minutes, Arterial pH level <7.20<br>