Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour

• ClinicalTrials.gov Identifier: NCT01563939
• Recruitment Status: Terminated
• First Posted: March 27, 2012
• Last Update Posted: September 4, 2015
• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Information provided by (Responsible Party): Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Remifentanil	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• 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
• Study Start Date: February 2012
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. Maternal satisfaction [ Time Frame: 24 hours ]
   Maternal satisfaction rated from 0-10, throughout labour
2. Consumption of remifentanil [ Time Frame: 24 hours ]
   remifentanil consumed in mg/hr
3. Crossover to epidural [ Time Frame: 24 hours ]
   Time to crossover if the patient decides to have an epidural
4. Side effects [ Time Frame: 24 hours ]
   Sedation score, Heart Rate, Blood Pressure, Nausea, Vomiting, Pruritis
5. 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.

Eligibility Criteria

• 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

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

More Information

• Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• ClinicalTrials.gov Identifier: NCT01563939
• Other Study ID Numbers: 12-02
• 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