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

NCT ID: NCT02512783

Last Updated: 2016-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-06-30

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Lidocaine

Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation

Propofol

Intervention Type: DRUG

Intravenous administration of propofol according to standard care to sedate patient.

Normal Saline

Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation

Propofol

Intervention Type: DRUG

Intravenous administration of propofol according to standard care to sedate patient.

Interventions

Lidocaine

Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation

Intervention Type: DRUG

Normal Saline

Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation

Intervention Type: DRUG

Propofol

Intravenous administration of propofol according to standard care to sedate patient.

Intervention Type: DRUG

Other Intervention Names

Xylocaine; Diprivan; Fresenius Propoven

Eligibility 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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospitals and Clinics of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didima Mon-Sprehe, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospitals and Clinics of Minnesota

Locations

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

1302-019

Identifier Type: -

Identifier Source: org_study_id