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Efficacy of Pre- and Post-Operative Oral Dextromethorphan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00199303
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Khon Kaen University
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Pre- and Post-Operative Oral Dextromethorphan for Reduction of Intra- and 24-Hr Post-Operative Morphine Consumption for Transabdominal Hysterectomy

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00199303     History of Changes
Other Study ID Numbers: efficacy of dextromethorphan
KhonKaen University
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: December 9, 2005
Last Verified: July 2002

Keywords provided by Khon Kaen University:
NMDAreceptor antagonist, dextromethorphan
pain, post-operative
opioid consumption, morphine

Additional relevant MeSH terms:
Morphine
Dextromethorphan
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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