Efficacy of Pre- and Post-Operative Oral Dextromethorphan

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00199303
• Other study ID #: efficacy of dextromethorphan
• Secondary ID: KhonKaen Univers
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: December 2002
• Est. completion date: December 2003

Study information

• Verified date: July 2002
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Efficacy of Dextromethorphan
• Morphine Consumption
• Pain

Intervention

Drug:
• pre-operatively followed by 30 mg three times per day after surgery

Locations

Country	Name	City	State
Thailand	Waraporn Chau-in	KhonKaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean morphine consumption
Primary	Mean pain score