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

NCT02512783 | Terminated Results

• 1 other identifier: 1302-019
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Propofol; Lidocaine; Intravenous propofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parental Assessment of Child's Pain on a Visual Analog Scale

  Immediately following propofol injection

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

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

Drug: Lidocaine; Drug: Propofol

Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal Saline; Drug: Propofol

Interventions

Lidocaine DRUG

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

Also known as: Xylocaine

Lidocaine

Normal Saline DRUG

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

Normal Saline

Propofol DRUG

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

Also known as: Diprivan, Fresenius Propoven

Lidocaine; Normal Saline

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Saline Solution; Propofol

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Angela Doucette
• Organization: Children's Hospitals and Clinics of Minnesota

angela.doucette@childrensmn.org

6128137144

Study Officials

• Didima Mon-Sprehe, MD

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: July 31, 2015
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 21, 2016
• Results First Posted: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)