Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status: Terminated

Conditions: Pain

Treatments: Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT01563939

12-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups

Continuous infusion

Active Comparator group

Description:

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

Treatment:

Drug: Remifentanil

Demand Bolus

Active Comparator group

Description:

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

Treatment:

Drug: Remifentanil