Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01563939
• Other study ID #: 12-02
• Status: Terminated
• Phase: N/A
• First received: March 23, 2012
• Last updated: September 2, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Maternal satisfaction	Maternal satisfaction rated from 0-10, throughout labour	24 hours	No
Secondary	Consumption of remifentanil	remifentanil consumed in mg/hr	24 hours	No
Secondary	Crossover to epidural	Time to crossover if the patient decides to have an epidural	24 hours	No
Secondary	Side effects	Sedation score, Heart Rate, Blood Pressure, Nausea, Vomiting, Pruritis	24 hours	Yes
Secondary	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	Yes