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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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24756
Enrollment
80
Registered
2019-07-02
Start date
2020-06-11
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Labour pain

Interventions

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

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

MeasureTime 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

MeasureTime 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

Public ContactMarjolein Lansbergen-Mensink

Reinier de Graaf

Marjolein1.Lansbergen@rdgg.nl0031152603769

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)