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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02512783
• Other study ID #: 1302-019
• Status: Terminated
• Phase: N/A
• First received: August 15, 2013
• Last updated: July 29, 2015
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 parent will then be asked to rate the child's discomfort using the visual analog 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.

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. The parent will then be asked to rate the child's discomfort using the visual analog scale.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 17 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
• Normal Saline
Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
• Propofol
Intravenous administration of propofol according to standard care to sedate patient.

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FLACC (Face, Legs, Activity, Cry, Consolability) score		1 minute following propofol induction	No
Secondary	Parental assessment of child's pain on a visual analog scale		5 minutes following propofol induction	No