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

Akron Children's Hospital

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: normal saline; Drug: lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00786916

080209

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 2 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 3 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

Saline

Treatment:

Drug: normal saline

Group B

Active Comparator group

Description:

Lidocaine 0.25 mg/kg

Treatment:

Drug: lidocaine

Drug: lidocaine

Group C

Active Comparator group

Description:

Lidocaine 0.5 mg/kg

Treatment:

Drug: lidocaine

Drug: lidocaine