NCT00373464

Brief Summary

The aim of this trial is to compare if a single dose of oral etoricoxib 120 mg will have equal post-operative analgesic efficacy as an optimal regiment of intravenous ketorolac 30 mg + 30 mg during the first 18 hours (+/- 1 hour) after gynaecologic laparoscopic surgical procedures, where the need for post-operative opioid is expected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

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

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

July 1, 2011

Status Verified

August 1, 2005

First QC Date

September 6, 2006

Last Update Submit

June 30, 2011

Conditions

HysterectomyTubal ExcisionOvariectomyPostoperative Pain

Keywords

Postoperative painOpioidEtoricoxibKetorolacLaparoscopic SurgerySurgical Procedures, Gynecologic

Outcome Measures

Primary Outcomes (1)

  • Equal opioid consumption in both groups postoperatively

Secondary Outcomes (1)

  • Equal visual analogue scale (VAS) and verbal rating scale (VRS) in the first 4 hours

Interventions

etoricoxibDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (American Society of Anaesthesiologists \[ASA\] I and II) due for elective, laparoscopic gynaecologic surgery with the expected need for post-operative opioids: hysterectomy, removal of tube(s) and/or ovarium.
  • Written informed consent.
  • Weight between 50 and 120 kg.

You may not qualify if:

  • Patients who use nonsteroidal anti-inflammatory agents (NSAIDs) in the last 48 hours (h) before surgery or are allergic to NSAIDs. Patients using steroids, anti-emetic drugs, or opioids in the last 48 h before surgery.
  • Sensitivity to the study drug or its components.
  • Cardiovascular risk conditions: heart failure, unstable hypertension, coronary artery disease (i.e. angina, previous myocardial infarction, previous coronary artery bypass surgery).
  • Cerebrovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, Oslo County, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johan Ræder, Prof.MD,PhD

    Ullevaal University Hospital

    STUDY DIRECTOR

  • Harald Lenz, MD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

March 1, 2006

Study Completion

March 1, 2007

Last Updated

July 1, 2011

Record last verified: 2005-08

Locations

NO(1)