Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery

A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00633438

Enrollment

204

Registered

2008-03-12

Start date

2004-01-31

Completion date

2004-06-30

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroscopy

Keywords

Knee Surgery Arthroscopic Surgery

Brief summary

To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients

Interventions

OTHERPlacebo

Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed

DRUGCelecoxib

400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Inclusion criteria: * Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery * Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

Design outcomes

Primary

Measure	Time frame
Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery	24 hours

Secondary

Measure	Time frame
Time to analgesic use after surgery	1, 2, 6, 8, 10, 12, 24, 36 hours
Number and percentage of patients taking HC/APAP after surgery	1, 2, 6, 8, 10, 12, 24, 36 hours
Adverse events	Day 7
Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion	1, 2, 6, 8, 10, 12, 24, 36 hours
Vital signs	Day 7
Laboratory evaluation	Day 7
Physical exam	Day 7

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026