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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49620

Enrollment

Registered

2019-11-06

Start date

2020-06-15

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pijn/ pijnbehandeling contractions Labour pain

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
The sample size calculation will be performed on the primary outcome: administered Remifentanil doses after 60 minutes. Further analysis will be performed on 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	—

Countries

Netherlands

Outcome results