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

Paracetamol is the primary option for treatment of acute pain.In the
Netherlands, the primary choice for treating labour pain is epidural analgesia,
followed by Remifentanil/ Patient Controlled Analgesia. The limited research
of the use of Paracetamol for management of labour pain shows that Paracetamol
provides similar pain relief, with fewer side effects, compared to Tramadol or
Pethidine.One study shows that Paracetamol as an adjunct to Patient Controlled
Epidural Analgesia shows lower opioid consumption compared to Saline as
adjunct. Also, duration of labour might be shortened when Paracetamol is used
intrapartum.The moment Remifentanil was introduced in the Dutch obstetrical
care, intravenous Paracetamol was not yet available on the Dutch market.
Complications with use of Remifentanil are rare, but severe: desaturation,
hypopnoea and bradycardia. Studies concerning postoperative multimodal pain
management show that adding Paracetamol to treatment with opioids reduces
opioid use. Paracetamol might reduce Remifentanil use when added to treatment
as intrapartum pain management as Patient Controlled Analgesia.

Primary objective: to research if Paracetamol reduces Remifentanil use when
added to Remifentanil/PCA pain management during labour.

Patients: Women in labour, using Remifantanil as pain management
Intervention: Paracetamol intravenous (1 gram, Paracetamol Fresenius Kabi 10
mg/ml)
Control: Placebo intravenous (100 ml Saline)
Outcome: Remifantanil/PCA requests and administered doses

Single centre double-blind randomised placebo controlled intervention trial.

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.