Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: Remifentanil

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous infusion; Remifentanil administered by continuous IV infusion, with stepwise increase in infusion rates and placebo demand bolus of normal saline.	Drug: Remifentanil; Remifentanil IV for continuous infusion: 0.025mcg/kg/min, increased by 0.025mcg/kg/min every 15 min if patient is not satisfied, to a maximum of 0.15mcg/kg/min. Remifentanil IV for demand bolus: 0.2 mcg/kg, lockout 2 min, incrementally increased if patient is not satisfied by 0.2 mcg/kg to a maximum of 1.2 mcg/kg.; Other Names: remifentanil hydrochloride
Active Comparator: Demand Bolus; Demand bolus of remifentanil with stepwise increase in bolus dose and placebo continuous infusion of normal saline.	Drug: Remifentanil; Remifentanil IV for continuous infusion: 0.025mcg/kg/min, increased by 0.025mcg/kg/min every 15 min if patient is not satisfied, to a maximum of 0.15mcg/kg/min. Remifentanil IV for demand bolus: 0.2 mcg/kg, lockout 2 min, incrementally increased if patient is not satisfied by 0.2 mcg/kg to a maximum of 1.2 mcg/kg.; Other Names: remifentanil hydrochloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimate): March 27, 2012

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Pregnancy; Labour analgesia; IVPCA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 12-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No