Efficacy of Pre- and Post-Operative Oral Dextromethorphan | NCT00199303

Studies
Efficacy of Pre- and Post-Operative Oral Dextromethorphan

NCT00199303

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

Sep 20, 2005Estimated

Enrollment

100

Phase

Not Applicable

Conditions

Efficacy of Dextromethorphan
Morphine Consumption
Pain

Interventions

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

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KhonKaen University

Status Module

Record Verification Date

Jul 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2002

Primary Completion Date

Not provided

Completion Date

Dec 2003

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2005

Last Update Posted Date

Sep 20, 2005Estimated

Description Module

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)

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
pre-operatively followed by 30 mg three times per day after surgery	Drug

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Waraporn Chau-in		KhonKaen	KhonKaen	40002	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Mean morphine consumption
Mean pain score