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Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

This study is currently recruiting participants.
Verified November 2012 by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT01563939
First received: March 23, 2012
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Pain
 Drug: Remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour: is Demand Bolus Required for Optimal Analgesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

Primary Outcome Measures:
  • Pain score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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:
  • Maternal satisfaction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Maternal satisfaction rated from 0-10, throughout labour

  • Consumption of remifentanil [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    remifentanil consumed in mg/hr

  • Crossover to epidural [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Time to crossover if the patient decides to have an epidural

  • Side effects [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Sedation score, Heart Rate, Blood Pressure, Nausea, Vomiting, Pruritis

  • Fetal & Neonatal outcomes [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Non-reassuring fetal heart rate as determined by obstetrician, Neonatal weight, Apgar scores, naloxone administration, need for resuscitation, NICU admission.


Estimated Enrollment: 48
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: remifentanil hydrochloride

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563939

Contacts
Contact: Mrinalini Balki, MD 416-586-4800 ext 5270 mrinalini.balki@uhn.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Mrinalini Balki, MD     416-586-4800 ext 5270     mrinalini.balki@uhn.ca    
Sub-Investigator: Tamara Henderson, MD            
Sub-Investigator: Leyla Baghirzada, MD            
Sub-Investigator: Jose CA Carvalho, MD            
Principal Investigator: Mrinalini Balki, MD            
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Mrinalini Balki, MD Mount Sinai Hospital, New York
  More Information

No publications provided

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01563939     History of Changes
Other Study ID Numbers: 12-02
Study First Received: March 23, 2012
Last Updated: November 8, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Labour analgesia
Pregnancy
IVPCA

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 19, 2013