Labour pain
Conditions
Interventions
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Maternal parameters: Need for oxygen administration, frequency of vomiting, time to full dilatation in minutes from start of pain treatment, Neonatal parameters: Apgar Score=7 after 5 minutes, Arterial pH level <7.20 | — |
Contacts
Reinier de Graaf