The PaPa Trial: Paracetamol as an adjunct to intraPartum Remifentanil/PCA. An RCT of multimodal pain management during labor.

SUMMARY: The PaPa Trial: Paracetamol as an adjunct to intrapartum Remifentanil/PCA. An RCT of multimodal pain management during labour.
Rationale: Paracetamol is the primary option for treatment of acute pain. There is little research in obstetrics on the effect of Paracetamol on labour pain. In the Netherlands, the primary choice for treating labour pain is epidural analgesia, followed by Remifentanil/ Patient Controlled Analgesia. The moment Remifentanil was introduced in Dutch obstetrical care, intravenous Paracetamol was not yet available on the Dutch market. Complications with Remifentanil use are rare, but severe: desaturation, hypopnoea and bradycardia. More is known nowadays about multimodal pain management. Paracetamol might reduce opioid use when used as add-on pain medication combined with Remifentanil.
Objective: Primary objective: to research if Paracetamol ensures lower opioid intake when added to Remifentanil as intra-partum pain management.
Secondary objectives: monitoring opioid requests and administered doses of Remifentanil in an intervention (Paracetamol as add-on pain treatment) and control (Placebo combined with Remifentanil) group.
Study design: Single centre double-blind placebo controlled intervention study.
Study population: Healthy women in labour, > 18 years of age.
Intervention: The intervention group receives 1000 mg intravenous Paracetamol (Paracetamol Fresenius Kabi 10 mg/ml, total amount 100 ml) in 15 minutes combined with Patient Controlled Analgesia/ Remifentanil according to protocol. The control group receives a placebo: 100 ml Saline in 15 minutes combined with Patient Controlled Analgesia/ Remifentanil according to protocol.

Main study parameters/endpoints: Remifentanil bolus requests and actual administered Remifentanil doses. Secondary end points: need for oxygen administration, frequency of vomiting, time to full dilatation in minutes from start of pain treatment, Apgar Score.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Counselling for enrolment in the study might be a burden for the labouring woman. However, when need for pain treatment arises, counselling for Epidural Analgesia vs. Remifentanil/ PCA will take place anyhow. Further, the burden is minimal: number of Remifentanil requests and actual administered doses can be read from the infusion pump. The expectation is that the labouring woman will benefit from opioid reduction, with less desaturation, hypopnoea and bradycardia and therefore less need for administration of oxygen. Also, there is research on possible shorter duration of the dilatation process when Paracetamol is used as intra-partum pain management. Adverse effects of Paracetamol are rare.

Adding Paracetamol to treatment with Remifentanil/ Patient Controlled Analgesia for management of labour pain ("multimodal pain management") reduces opioid (Remifentanil) consumption

30, 60, 90, 120, 150, 180 minutes from zerotime: start of treatment with Remifentanil and either Paracetamol IV or Placebo.

Combining 1 gram Paracetamol intravenously with Remifentanil as intrapartum pain management.