Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

Condition(s) targeted: Pain

Intervention: Remifentanil (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Official(s) and/or principal investigator(s):
Mrinalini Balki, MD, Principal Investigator, Affiliation: Mount Sinai Hospital, New York

Overall contact:
Mrinalini Balki, MD, Phone: 416-586-4800, Ext: 5270, Email: mrinalini.balki@uhn.ca

Epidural analgesia for pain relief in labor may not be suitable for all patients, and intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative. The purpose of this study is to assess the effectiveness of two methods remifentanil administration in the form of either an infusion or PCA demand bolus (intravenous injection of a single dose over a short period of time). Currently, our hospital gives remifentanil by demand bolus, however it may be equally effective, with less side effects, to give the drug as an infusion.

Official title: Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour: is Demand Bolus Required for Optimal Analgesia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Pain score

Secondary outcome:

Maternal satisfaction

Consumption of remifentanil

Crossover to epidural

Side effects

Fetal & Neonatal outcomes

Detailed description: The study will be conducted as a randomized trial with two arms: Group I- continuous infusion of remifentanil with stepwise increase in infusion rates and Group II- demand bolus only with stepwise increase in bolus dose, as per the patient's analgesic requirement. Visual analog scores will be the primary outcome. Maternal and fetal side effects will be recorded. The results of this study will determine the regimen that suits the patients needs for painless labor with high efficacy, less adverse effects and a higher patient satisfaction.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Written informed consent

- Term pregnancy in labour with singleton fetus in cephalic presentation

- Patients requesting systemic analgesia

- Patients with contraindication for regional anesthesia without fetal compromise

(coagulopathy, thrombocytopenia, refusal, etc.) Exclusion Criteria:

- Refusal to sign written informed consent

- Inability to communicate in English

- Opioid dependence or addiction

- Patients on Methadone

- Allergy or hypersensitivity to remifentanil

- Fetal heart rate abnormalities

- Fetal congenital anomalies

Mrinalini Balki, MD, Phone: 416-586-4800, Ext: 5270, Email: mrinalini.balki@uhn.ca

Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; Recruiting
Mrinalini Balki, MD, Phone: 416-586-4800, Ext: 5270, Email: mrinalini.balki@uhn.ca
Tamara Henderson, MD, Sub-Investigator
Leyla Baghirzada, MD, Sub-Investigator
Jose CA Carvalho, MD, Sub-Investigator
Mrinalini Balki, MD, Principal Investigator

Starting date: February 2012
Last updated: October 9, 2014