NCT00199303

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

September 20, 2005

Status Verified

July 1, 2002

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Efficacy of DextromethorphanMorphine ConsumptionPain

Keywords

NMDAreceptor antagonist, dextromethorphanpain, post-operativeopioid consumption, morphine

Outcome Measures

Primary Outcomes (2)

  • Mean morphine consumption

  • Mean pain score

Interventions

pre-operatively followed by 30 mg three times per day after surgeryDRUG

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waraporn Chau-in

KhonKaen, KhonKaen, 40002, Thailand

Location

MeSH Terms

Conditions

PainPain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • waraporn chau-in, Asso Prof.

    Department of Anesthesiology, Faculty of Medicine,KhonKaen University,KhonKaen 40002, Thailand

    STUDY CHAIR

  • BUSABONG SUKMOUEN, Dr.

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

  • KRIANGSAK NGAMSANGSIRISAPT, Dr.

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

  • WINITA JIRARAREUNGSAK

    Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

December 1, 2002

Study Completion

December 1, 2003

Last Updated

September 20, 2005

Record last verified: 2002-07

Locations

TH(1)