NCT00664690

Brief Summary

Sixty adults having shoulder and forearm surgery will receive either placebo or celebrex started preoperatively and continued for 3 days. Rescue medications required as well as pain scores will be assessed using a patient diary to evaluate the effect of celebrex in controlling transitional pain

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

April 18, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

First QC Date

April 18, 2008

Last Update Submit

August 25, 2017

Conditions

Pain

Keywords

shoulder surgeryanalgesia

Outcome Measures

Primary Outcomes (1)

  • visual analogue score for pain

    post-op period

Secondary Outcomes (1)

  • severity of nausea

    post-op period

Study Arms (2)

1

EXPERIMENTAL

celebrex

Drug: celebrex

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

celebrexDRUG

400 mg celebrex given 1 hour preop and celebrex 200 mg BID postop

1
placeboDRUG

placebo given preop and BID postop

2

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for elective ambulatory surgery of the shoulder
  • ASA I - III
  • Able to read English
  • Male or female

You may not qualify if:

  • Allergy to local anesthetic, Cox2, sulpha drug, acetaminophen or oxycodone
  • Women who are pregnant or lactating and women of childbearing age and not following acceptable contraceptive precautions
  • Any major medical or psychiatric problem
  • Those with a known history of narcotic dependence, abuse or chronic narcotic intake
  • Patients with known history of peptic ulcer or GI bleeding in the past, ulcers, congestive heart failure, angina or previous heart attack, coagulation problems, venous thrombosis, kidney or liver disease or strokes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N, Canada

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ngozi Imasogie, MD

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 23, 2008

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

CA(1)