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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Normal Saline
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. | Drug: Lidocaine<br>* Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation<br>* Other names: Xylocaine;Drug: Propofol<br>* Intravenous administration of propofol according to standard care to sedate patient.<br>* Other names: Fresenius Propoven;|
| Placebo Comparator: Normal Saline<br>Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. | Drug: Normal Saline<br>* Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation<br>Drug: Propofol<br>* Intravenous administration of propofol according to standard care to sedate patient.<br>* Other names: Fresenius Propoven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score | 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. | 1 minute before propofol induction compared to 1 minute following propofol induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Assessment of Child's Pain on a Visual Analog Scale |  | Immediately following propofol injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Propofol, Lidocaine, Intravenous propofol