Phase 4
N=109
Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00786916 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Maximal Pain/Discomfort — 4.7; 4.3; 5.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- normal saline (Drug); lidocaine (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Akron Children's Hospital
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximal Pain/Discomfort |
4.7; 4.3; 5.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00786916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.