Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion

This study is ongoing, but not recruiting participants.

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00146926

Purpose

Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an incidence between 40 and 90%. Three different strategies to prevent propofol induced pain will be studied compared with placebo. Pain will be scored with a four-point scale.

Condition	Intervention	Phase
Induction of Total Intravenous General Anesthesia	Drug: kétamine 20mg Drug: ephedrine 3mg Drug: lidocaine 40mg	Phase III

MedlinePlus related topics: Anesthesia

Drug Information available for: Propofol Lidocaine Ketamine Ketamine hydrochloride Ephedrine Ephedrine Hydrochloride Pseudoephedrine hydrochloride Pseudoephedrine Sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness

Secondary Outcome Measures:

Explicite and implicite memory of pain immediately after surgery and on day one
Adverse effects

Estimated Enrollment:	200
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy adults (ASA 1-2) for scheduled surgery under general anesthesia with propofol

Exclusion Criteria:

pregnant
sedative or analgesic drug 24h before surgery
allergy with drug used in the study
difficulty of communication
absence of informed written consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146926

Locations

France
Grégoire CHATAIN
Lyon, France, 69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Vincent PIRIOU, MD

Hospices Civils de Lyon

More Information

Study ID Numbers:	2004.367
Study First Received:	September 5, 2005
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00146926
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Propofol
pain
general anesthesia
prevention

Study placed in the following topic categories:

Pseudoephedrine
Ketamine
Lidocaine

Ephedrine
Pain
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009