NL-OMON49620
Completed
Not Applicable
The PaPa Trial: Paracetamol as an adjunct to intrapartum Remifentanil/PCA. An RCT of multimodal pain management during labor. - The PaPa Trial
Reinier de Graaf Groep0 sites79 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Reinier de Graaf Groep
- Enrollment
- 79
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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