Efficacy of Pre- and Post-Operative Oral Dextromethorphan

Efficacy of Pre- and Post-Operative Oral Dextromethorphan for Reduction of Intra- and 24-Hr Post-Operative Morphine Consumption for Transabdominal Hysterectomy

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)

Study Overview

• Status: Completed
• Conditions: Pain; Morphine Consumption; Efficacy of Dextromethorphan
• Intervention / Treatment: Drug: pre-operatively followed by 30 mg three times per day after surgery

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.

• Study Type: Interventional
• Enrollment: 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • KhonKaen, Thailand, 40002
    • Waraporn Chau-in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean pain score
Mean morphine consumption

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Study Completion: December 1, 2003

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): September 20, 2005
• Last Update Submitted That Met QC Criteria: September 12, 2005
• Last Verified: July 1, 2002

More Information

Terms related to this study

• Keywords: NMDAreceptor antagonist, dextromethorphan; pain, post-operative; opioid consumption, morphine
• Other Study ID Numbers: efficacy of dextromethorphan; KhonKaen University