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Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

This study has been terminated.
(Difficult recruitment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563939
First Posted: March 27, 2012
Last Update Posted: September 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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:


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

Primary Outcome Measures:
  • Pain score [ Time Frame: 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:
  • Maternal satisfaction [ Time Frame: 24 hours ]
    Maternal satisfaction rated from 0-10, throughout labour

  • Consumption of remifentanil [ Time Frame: 24 hours ]
    remifentanil consumed in mg/hr

  • Crossover to epidural [ Time Frame: 24 hours ]
    Time to crossover if the patient decides to have an epidural

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

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


Enrollment: 2
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563939


Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
Principal Investigator: Mrinalini Balki, MD Mount Sinai Hospital, New York
  More Information

Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01563939     History of Changes
Other Study ID Numbers: 12-02
First Submitted: March 23, 2012
First Posted: March 27, 2012
Last Update Posted: September 4, 2015
Last Verified: September 2015

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

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