Diclofenac Administered Before Skull Operations Reduces the Severity of Headache After the Intervention

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Debrecen
• Treatments: Diclofenac; Midazolam

Criteria

Inclusion Criteria:

• Patients who were over the age of 18, able to cooperate and underwent elective craniotomy at the Department of Neurosurgery of the University of Debrecen.

• Patients with full awareness and without existing sensory or severe motor aphasia at admission or postoperatively.

• After written informed consent and written agreement was obtained from each participant.

Exclusion Criteria:

• Patients under the age of 18, patients who were unable to cooperate and who underwent traumatic or emergency interventions.

• Patients taking non-steroidal anti-inflammatory agents prior to surgery for any reasons were excluded from the study.