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

Not Applicable

Terminated

Brief 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.

Detailed Description: Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized.

The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

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 FLACC scale.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
Lidocaine	Propofol	Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
Lidocaine	Lidocaine	Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.
Normal Saline	Propofol	Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.

Primary Outcome Measures

Name	Time	Method
Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score	1 minute before propofol induction compared to 1 minute following propofol induction	The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.

Secondary Outcome Measures