Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

NCT01563939 | Terminated

• 1 other identifier: 12-02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Labour analgesia; Pregnancy; IVPCA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Maternal satisfaction

  24 hours

• Consumption of remifentanil

  24 hours

• Crossover to epidural

  24 hours

• Side effects

  24 hours

• Fetal & Neonatal outcomes

  48 hours

Study Arms (2)

Continuous infusion

ACTIVE COMPARATOR

Remifentanil administered by continuous IV infusion, with stepwise increase in infusion rates and placebo demand bolus of normal saline.

Drug: Remifentanil

Demand Bolus

ACTIVE COMPARATOR

Demand bolus of remifentanil with stepwise increase in bolus dose and placebo continuous infusion of normal saline.

Drug: Remifentanil

Interventions

Remifentanil DRUG

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.

Also known as: remifentanil hydrochloride

Continuous infusion; Demand Bolus

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

CA (1)