Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospitals and Clinics of Minnesota
• Treatments: Lidocaine; Propofol

Criteria

Inclusion Criteria:

• age 2 months to 17 years

• patient already scheduled for procedural sedation with propofol

• sedation procedure to be performed by a sedationist from Children's Respiratory and Critical Care Specialists

Exclusion Criteria:

• patients who are not receiving deep sedation with propofol

• patients with allergy or other contraindication to lidocaine administration

• patients with central venous catheters as propofol does not burn when given centrally

• patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine

• patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.