Diclofenac Administered Before Skull Operations Reduces the Severity of Headache After the Intervention
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|ClinicalTrials.gov Identifier: NCT01907984|
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : July 25, 2013
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.
100 mg preoperatively given diclofenac significantly reduces the incidence and severity of postcraniotomy headache.
|Condition or disease||Intervention/treatment||Phase|
|Postcraniotomy Headache Intraoperative Analgesic Use Postoperative Analgesic Use Postoperative Complications||Drug: Diclofenac Drug: Midazolam||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Preoperatively Administered Single Dose Diclofenac Reduces the Intensity of Acute Postcraniotomy Headache and Decreases Postoperative Analgesic Requirements- a Randomized, Controlled Trial|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: Diclofenac and Midazolam
Diclofenac 100 mg tablet and Midazolam 7.5 mg tablet were administered by mouth as premedication 30 minutes before surgical interventions.
Other Name: Dormicum
Active Comparator: Midazolam
Midazolam 7.5 g tablet was administered as premedication by mouth 30 minutes before surgical interventions.
Other Name: Dormicum
- Severity of headache was measured with Visual Analog Scale (VAS) [ Time Frame: Changes from Baseline in Visual Analog Scale assessed at the first postoperative day ]Severity of pain was assessed using a visual analogue scale 24 hours preoperatively, on the day of surgery 30 minutes before the operation, the current severity of headache on the first and fifth postoperative days and the strongest pain experienced since the last Visual Analog Scale assessments.
- Severity of headache was measured with Visual Analog Scale (VAS) [ Time Frame: Changes from Baseline in Visual Analog Scale assessed at the 5. postoperative day ]Severity of pain was assessed using a visual analogue scale 24 hours preoperatively, on the day of surgery 30 minutes before the operation, the current severity of headache on the first and fifth postoperative days and the strongest pain experienced since the last Visual Analog Scale assessments.
- Severity of postcraniotomy headache within supra- and infratentorial sub-groups. [ Time Frame: Changes from Baseline in Visual Analog Scale assessed at the first and fifth postoperative day ]Patients were sub-grouped according to the site of the surgical intervention, either supra- or infratentorial skull surgery, the severity of PCH was measured among these groups by means of Visual Analog Scale.
- Analgesic need during the first five postoperative days. [ Time Frame: Participants were followed for 5 days postoperatively ]The total amount of analgesics administered were recorded during the first five postoperative days and then converted into intramuscular morphine equivalents.
- Postoperative complications during the first five postoperative days [ Time Frame: Participants were followed for 5 days postoperatively ]Postoperative complications such as bleeding at the surgical site, gastrointestinal problems or kidney dysfunctions were also registered.
- Intraoperative fentanyl use [ Time Frame: Participants were followed during the operation on day 1. ]Intraoperative fentanyl use was registered as micrograms per kilogram body weight and micrograms per hour as well.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907984
|University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care|
|Debrecen, Hajdú-Bihar, Hungary, 4032|
|Principal Investigator:||Csilla Molnár, MD, PhD||University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care 4032-Debrecen, Nagyerdei krt 98. Hungary Tel/fax: +36-52-255-347|