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Efficacy of Pre- and Post-Operative Oral Dextromethorphan

NCT ID: NCT00199303

Last Updated: 2005-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-12-31

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Efficacy of Dextromethorphan Morphine Consumption Pain

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Principal Investigators

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waraporn chau-in, Asso Prof.

Role: STUDY_CHAIR

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

BUSABONG SUKMOUEN, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

KRIANGSAK NGAMSANGSIRISAPT, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

WINITA JIRARAREUNGSAK

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology

Locations

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Waraporn Chau-in

KhonKaen, KhonKaen, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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KhonKaen University

Identifier Type: -

Identifier Source: secondary_id

efficacy of dextromethorphan

Identifier Type: -

Identifier Source: org_study_id