Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Drug: Remifentanil

• Registration Number: NCT01563939
• Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion	Remifentanil	Remifentanil administered by continuous IV infusion, with stepwise increase in infusion rates and placebo demand bolus of normal saline.
Demand Bolus	Remifentanil	Demand bolus of remifentanil with stepwise increase in bolus dose and placebo continuous infusion of normal saline.

Primary Outcome Measures

Name	Time	Method
Pain score	24 hours	Verbal Numeric Rating Scale (VNRS) from 0 to 10 (where 0 = no pain and 10 = worst pain felt), approximately every hour, throughout labour.

Secondary Outcome Measures

Name	Time	Method
Consumption of remifentanil	24 hours	remifentanil consumed in mg/hr
Crossover to epidural	24 hours	Time to crossover if the patient decides to have an epidural
Side effects	24 hours	Sedation score, Heart Rate, Blood Pressure, Nausea, Vomiting, Pruritis
Fetal & Neonatal outcomes	48 hours	Non-reassuring fetal heart rate as determined by obstetrician, Neonatal weight, Apgar scores, naloxone administration, need for resuscitation, NICU admission.
Maternal satisfaction	24 hours	Maternal satisfaction rated from 0-10, throughout labour

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada