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Pre-Emptive Analgesia Efficacy of Etoricoxib for Postoperative Pain

A Randomized, Double-Blind, Controlled Trial of Etoricoxib as a Pre-Emptive Analgesic for Abdominal Hysterectomy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00149253
Enrollment
50
Registered
2005-09-08
Start date
2004-12-31
Completion date
2005-05-31
Last updated
2005-09-08

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

Conditions

a Single-Dose of Etoricoxib, Post-Operative Morphine Consumption, Post Transabdominal Hysterectomy, Total Pain Relief Over 8 Hr(TOPAR8)

Keywords

Abdominal hysterectomy,, Etoricoxib,, morphine consumption,, pre-emptive analgesia

Brief summary

Taken together, studies of the value of pre-emptive analgesia are inconclusive. This randomized, double-blind, dose-ranging, placebo-controlled study was therefore designed to test that a reduction in post-operative morphine consumption can be achieved by a single-dose of etoricoxib before induction of anesthesia.

Detailed description

Patients undergoing transabdominal hysterectomy were randomized to a group taking a single dose (orally) of etoricoxib 120 mg (n = 18), etoricoxib 180 mg (n = 17) or placebo (n = 15) 2 hours before surgery under the same standardized general anesthesia. At the post-anesthetic care unit, intravenous morphine titration was given before starting self-controlled analgesia (PCA) device. Morphine consumption, pain relief score, sedative score, global evaluation score, and side-effects were recorded at 1, 2, 4, 8 and 24 h post-operatively. The primary end points were morphine consumption within 24-hr post-operatively and total pain relief over 8 h (TOPAR8). Patient global satisfaction was also assessed.

Interventions

DRUGa single-dose of Etoricoxib before induction of anesthesia

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* The ASA I or II patients undergoing elective transabdominal hysterectomy with general anesthesia

Exclusion criteria

* Patients with history of opioid addiction or chronic pain * Allergy to other nonsteroidal anti-inflammatory, or asthma * Concomitant use of tricyclic antidepressants, opioid analgesics, antihistamines, tranquilizers, hypnotics, sedatives, or systemic corticosteroids * Those unable to understand the principle of patient-controlled analgesia(PCA) device were excluded from the study

Design outcomes

Primary

MeasureTime frame
The primary end points were morphine consumption within 24-hr post-operatively
and total pain relief over 8 h (TOPAR8).

Secondary

MeasureTime frame
Patient global response to therapy

Countries

Thailand

Outcome results

None listed

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