Efficacy of Intravenous Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Procedural Sedation
Overview
- Phase
- Phase 4
- Intervention
- normal saline
- Conditions
- Pain
- Sponsor
- Akron Children's Hospital
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Maximal Pain/Discomfort
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Michael D. Reed
Pharm.D.
Akron Children's Hospital
Eligibility Criteria
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
Arms & Interventions
Group A
Saline
Intervention: normal saline
Group B
Lidocaine 0.25 mg/kg
Intervention: lidocaine
Group C
Lidocaine 0.5 mg/kg
Intervention: lidocaine
Outcomes
Primary Outcomes
Maximal Pain/Discomfort
Time Frame: 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.