NCT00520338

Brief Summary

The purpose of this study is to determine whether celecoxib is effective in the treatment postoperative pain after thyroidectomy. The research hypothesis: There is a difference in postoperative morphine consumption in the first 24 hours after thyroidectomy between patients who received celecoxib or placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Aug 2007

Typical duration for phase_4 postoperative-pain

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

August 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 9, 2010

Status Verified

November 1, 2010

Enrollment Period

2.3 years

First QC Date

August 22, 2007

Last Update Submit

November 6, 2010

Conditions

Postoperative PainThyroidectomyCyclooxygenase 2 Inhibitors

Keywords

celecoxibpostoperative painthyroidectomy

Outcome Measures

Primary Outcomes (1)

  • The patients' total amount of morphine requirement in the first 24 hour.

    24 hour

Study Arms (2)

2

PLACEBO COMPARATOR

1. placebo 2. celecoxib

Drug: celecoxib

1

NO INTERVENTION

1 placebo

Interventions

celecoxibDRUG

1. placebo 2. celecoxib 400 mg oral single dose

Also known as: celebrex
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient ASA physical status I-III.
  • Scheduled for an elective thyroidectomy.
  • Body weight \> or = 40kg
  • Can operate a patient-controlled analgesia (PCA) device.

You may not qualify if:

  • History of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs.
  • Known hypersensitivity to morphine or sulfonamides.
  • History of hepatic dysfunction.
  • Creatinine clearance \< 30ml/min.
  • History of bleeding tendency.
  • History of gastrointestinal bleeding or active peptic ulcer.
  • Known case of inflammatory bowel disease.
  • Patient with severe heart failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sirilak Suksompong, MD

    Department of anesthesiology. Siriraj Hospital, Mahidol University, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 24, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 9, 2010

Record last verified: 2010-11

Locations

TH(1)