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CompletedNCT00199303Updated Sep 20, 2005

Efficacy of Pre- and Post-Operative Oral Dextromethorphan

An interventional study of pre-operatively followed by 30 mg three times per day after surgery in Efficacy of Dextromethorphan, Morphine Consumption and Pain, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to female participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-09-20.

Sponsored by Khon Kaen University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
Female
01

Study 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)

Read the 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.

02

Conditions studied

  • Efficacy of Dextromethorphan
  • Morphine Consumption
  • Pain

Keywords

  • NMDAreceptor antagonist, dextromethorphan
  • pain, post-operative
  • opioid consumption, morphine
03

In context

Lead sponsor

Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
100 participants

Interventions

  • Drugpre-operatively followed by 30 mg three times per day after surgery
06

What researchers measure

Primary outcomes

  1. Mean morphine consumption

  2. Mean pain score

07

Study locations

1 site
  • Waraporn Chau-in
    KhonKaen, 40002, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 20, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00199303
Lead sponsor
Khon Kaen University
First posted
Sep 20, 2005
Start date
Dec 2002
Completion
Dec 2003
Last update
Sep 20, 2005

Study contacts

waraporn chau-in, Asso Prof.
study chair · Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand
BUSABONG SUKMOUEN, Dr.
principal investigator · Department of Anesthesiology
KRIANGSAK NGAMSANGSIRISAPT, Dr.
principal investigator · Department of Anesthesiology
WINITA JIRARAREUNGSAK
principal investigator · Department of Anesthesiology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2002. You cannot join it, but the record below documents what was studied.

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