Efficacy of Pre- and Post-Operative Oral Dextromethorphan - Full Text View

Sponsored by:	Khon Kaen University
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00199303

Purpose

We studied the effect of dextromethorphan (DEX), an N-methyl-d-aspartate antagonist, on analgesic consumption and pain scoring after abdominal hysterectomy. Our aim was to compare the analgesic effectiveness and incidence of adverse side effects of oral DEX with placebo (P)

Condition	Intervention
Efficacy of Dextromethorphan Morphine Consumption Pain	Drug: pre-operatively followed by 30 mg three times per day after surgery

MedlinePlus related topics: Hysterectomy

Drug Information available for: Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Pre- and Post-Operative Oral Dextromethorphan for Reduction of Intra- and 24-Hr Post-Operative Morphine Consumption for Transabdominal Hysterectomy

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:

Mean morphine consumption
Mean pain score

Estimated Enrollment:	100
Study Start Date:	December 2002
Estimated Study Completion Date:	December 2003

Detailed Description:

One hundred patients were randomized to two groups. Group DEX was given 30 mg tablets of oral dextromethorphan with their pre-medication and three more times in the first 24 hours after surgery. Group P received the placebo following the same schedule. Post-operative analgesic requirements were assessed using a patient-controlled analgesia system.

Pain was assessed at rest using a visual analog scale in the post anesthetic care unit(PACU), 6 and 24 hours after surgery.

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

women aged between 30 and 60, with an ASA physical status of I or II, undergoing elective total abdominal hysterectomy under general anesthesia.

Exclusion Criteria:

Women with a history of significant renal or hepatic impairment, allergy to any of the study medications, antitussive or NSAID use (48 hours or 1 week, respectively) before surgery, chronic pain and regular analgesic use, were excluded. Patients taking medications that could interact with dextromethorphan, including quinidine, flecainide, mexiletine, fluoxetine, amitriptyline, nortriptyline, and propafenone

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00199303

Locations

Thailand
Waraporn Chau-in
KhonKaen, Thailand, 40002

Sponsors and Collaborators

Khon Kaen University

Investigators

Study Chair:	waraporn chau-in, Asso Prof.	Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand
Principal Investigator:	BUSABONG SUKMOUEN, Dr.	Department of Anesthesiology
Principal Investigator:	KRIANGSAK NGAMSANGSIRISAPT, Dr.	Department of Anesthesiology
Principal Investigator:	WINITA JIRARAREUNGSAK	Department of Anesthesiology

More Information

Study ID Numbers:	efficacy of dextromethorphan, KhonKaen University
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00199303
Health Authority:	Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:

NMDAreceptor antagonist, dextromethorphan
pain, post-operative
opioid consumption, morphine

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Excitatory Amino Acids
Morphine
Guaifenesin

Phenylephrine
Dextromethorphan
Pain
Phenylpropanolamine
Pain, Postoperative

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Excitatory Amino Acid Agents
Antitussive Agents
Central Nervous System Agents
Pharmacologic Actions
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 15, 2009