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Etoricoxib in Ear Nose Throat Surgery

NCT00756873 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2008-09-22

No results posted yet for this study

Summary

The aim of this study is to test the analgesic efficacy of etoricoxib (90 mg or 120 mg qd. perioperatively) for post-operative pain relief.

The primary endpoint is as follows:

* does preoperative etoricoxib reduce the post-operative opioid utilization in patients undergoing elective tonsillectomy under general anaesthesia (i.e. the post-operative opioid-sparing effect of etoricoxib in humans).

The secondary endpoints are as follows:

* does the etoricoxib medication have an impact on PONV or activities of daily
* does the etoricoxib medication influence the blood loss during surgery or the incidence of postoperative bleeding
* does the etoricoxib medication influence the operation time. In addition, adverse effects of etoricoxib will be documented.

Conditions

  • Tonsillectomy

Interventions

DRUG

Administration of placebo

Placebo qd orally day 0-14

DRUG

Administration of etoricoxib

Etoricoxib 90 mg qd orally day 0-14

DRUG

Administration of etoricoxib

Etoricoxib 120 mg qd orally day 0-7 Etoricoxib 90 mg qd orally day 8-14

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00756873 on ClinicalTrials.gov