Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: normal saline; Drug: lidocaine

• Registration Number: NCT00786916
• Lead Sponsor: Akron Children's Hospital

Brief Summary

This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term deep sedation in children. Patients will be randomized to receive either placebo (saline) or one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The efficacy of the differing lidocaine doses will be compared to determine the minimum dose required to safely achieve alleviation of pain. We hypothesize that premedicating with lidocaine will significantly decrease pain experienced by pediatric patients receiving propofol for outpatient sedation.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2013-01-23
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-26
• Last Update Submitted: 2015-02-26
• Results First Posted: 2015-02-27
• Last Update Posted: 2015-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• scheduled for painless diagnostic procedures
• are ASA I or ASA II

Exclusion Criteria

• have an indwelling central venous catheter
• have received an analgesic or sedative medication in the previous four hours prior to enrollment
• have an underlying chronic disorder that would impact on their ability to express distress when in painful or otherwise anxiety-provoking situations
• known hypersensitivity to lidocaine or any component of the formulation
• hypersensitivity to another local anesthetic of the amide type
• Adam-Stokes syndrome
• severe degrees of SA, AV, or intraventricular heart block
• allergy to corn-related products
• contraindication to propofol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	normal saline	Saline
Group B	lidocaine	Lidocaine 0.25 mg/kg
Group C	lidocaine	Lidocaine 0.5 mg/kg

Primary Outcome Measures

Name	Time	Method
Maximal Pain/Discomfort	during initial 3 minute propofol infusion	FLACC (Face, Legs, Activity, Cry, Consolability) Pain assessment scale was administered by a trained observer. The patient's parent documented maximum distress using a 100-mm visual analog scale where "0" represented "no pain" and 100 (the furthest point to the left) represented the worst pain ever.

Trial Locations

Locations (1)

Akron Children's Hospital; 🇺🇸 Akron, Ohio, United States