The PaPa Trial: Paracetamol as an adjunct to intrapartum Remifentanil/PCA. An RCT of multimodal pain management during labor.
Completed
- Conditions
- Pijn/ pijnbehandelingcontractionsLabour pain10010273
- Registration Number
- NL-OMON49620
- Lead Sponsor
- Reinier de Graaf Groep
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 79
Inclusion 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.
Exclusion Criteria
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 Acetaminophen/ Paracetamol
Severe nutritional deficiency
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The sample size calculation will be performed on the primary outcome:<br /><br>administered Remifentanil doses after 60 minutes. Further analysis will be<br /><br>performed on Remifentanil bolus requests and actual administered Remifentanil<br /><br>doses at 30, 60, 90, 120, 150, 180 minutes from zerotime: start of treatment<br /><br>with Remifentanil and either Paracetamol IV or Placebo. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Maternal parameters: Need for oxygen administration, frequency of vomiting,<br /><br>time to full dilatation in minutes from start of pain treatment,<br /><br>Neonatal parameters: Apgar Score*7 after 5 minutes, Arterial pH level <7.20</p><br>