NCT00405522

Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children

Co-administration of Propofol and Remifentanil for Lumbar Puncture in Children: Evaluation of Two Dose Combinations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare intraoperative and recovery parameters in patients who receive two different dose combinations of propofol and remifentanil in patients undergoing a lumbar puncture.

Detailed description

Lumbar punctures (LP) are performed in approximately one thousand oncology patients per year at the Hospital for Sick Children. In a previous study, we determined the optimal dose of remifentanil which provides effective anesthesia with little or no movement during LP in children. The present study will determine the optimal dose combination of propofol and remifentanil to keep patients comfortable and still during the procedure while decreasing the incidence of side effects and allows for shorter recovery times and earlier discharge from the recovery room.

Conditions

• Spinal Puncture

Interventions

Type	Name	Description
DRUG	Propofol 2.0 mg/kg + Remifentanil 1.5 ug/kg	Patients in this arm of the study will receive 2.0 mg/kg propofol + 1.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.
DRUG	Propofol 4.0 mg/kg + Remifentanil 0.5 ug/kg	Patients in this arm of the study will receive 4.0 mg/kg propofol + 0.5 ug/kg remifentanil. An anesthesiologist will inject propofol mixed with lidocaine, followed immediately by remifentanil, diluted with 0.9% saline to a volume of 3 ml and administered as a bolus.

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-11-30
• Last updated: 2019-03-08
• Results posted: 2019-03-08

Locations

1 site across 1 country: Canada