CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
Diclofenac +1 moredrug
Likely dose
Not stated in record
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Search/NCT01907984
NCT01907984Phase 4Completed

Preoperatively Administered Single Dose Diclofenac Reduces the Intensity of Acute Postcraniotomy Headache and Decreases Postoperative Analgesic Requirements- a Randomized, Controlled Trial

University of Debrecen·interventional·Posted Jul 25, 2013·Updated Jul 25, 2013

In Brief

A Phase 4 clinical trial evaluating Diclofenac and Midazolam for Postcraniotomy Headache and 3 related conditions. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Purpose: According to the proposal of the International Headache Society acute postcraniotomy headache (PCH) is defined as a headache of variable intensity, being most serious at the site of surgical intervention and developing within 7 days after craniotomy. Typically, pain resolves within 3 months after surgery. According to the literature the incidence of acute PCH during the postoperative period is 60% among patients undergoing elective craniotomies. No standardized international guidelines are available on the treatment of PCH to the present day. Treatment methods can be different based on the country and institution where they are used, or even physicians individually can have distinct medication regime, which sometimes happens to be habitual and lacks clinical evidences. The Department of Anesthesiology and Intensive Care Medicine at the University of Debrecen has been giving 100 mg diclofenac with analgesic purpose, as part of the premedication to neurosurgical patients for several years. It was observed that the postoperative headache following craniotomy was milder comparing to data published in the international literature. A pilot study was carried out with similar settings which found the that incidence of PCH was lower and less analgesics were required without any further unwanted side-effects among patients who received 100 mg diclofenac as part of the premedication. Hypothesis: 100 mg preoperatively given diclofenac significantly reduces the incidence and severity of postcraniotomy headache.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHungary
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 25, 2013
Enrollment StartDec 1, 2012
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.9 years ago

Interventions

Diclofenacdrug

Midazolamdrug