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Preoperatively Administered Single Dose Diclofenac Reduces the Intensity of Acute Postcraniotomy Headache and Decreases Postoperative Analgesic Requirements- a Randomized, Controlled Trial
Sponsor study identifier
Secondary identifiers
OTHER · University of Debrecen,RKEB/IKEB
interventional
200
1 country
1
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 2013
Actual (reported)April 2013
Actual (reported)July 11, 2013
Actual (reported)July 25, 2013
Actual (reported)Severity of headache was measured with Visual Analog Scale (VAS)
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.
Changes from Baseline in Visual Analog Scale assessed at the first postoperative day
Severity of headache was measured with Visual Analog Scale (VAS)
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.
Changes from Baseline in Visual Analog Scale assessed at the 5. postoperative day
Diclofenac 100 mg tablet and Midazolam 7.5 mg tablet were administered by mouth as premedication 30 minutes before surgical interventions.
Midazolam 7.5 g tablet was administered as premedication by mouth 30 minutes before surgical interventions.
University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, 4032, Hungary
De Benedittis G, Lorenzetti A, Migliore M, Spagnoli D, Tiberio F, Villani RM. Postoperative pain in neurosurgery: a pilot study in brain surgery. Neurosurgery. 1996 Mar;38(3):466-9; discussion 469-70. doi: 10.1097/00006123-199603000-00008.
Rocha-Filho PA, Gherpelli JL, de Siqueira JT, Rabello GD. Post-craniotomy headache: characteristics, behaviour and effect on quality of life in patients operated for treatment of supratentorial intracranial aneurysms. Cephalalgia. 2008 Jan;28(1):41-8. doi: 10.1111/j.1468-2982.2007.01465.x. Epub 2007 Nov 6.
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
200 participants (actual enrollment reported by the registry).
First Submitted
July 11, 2013
First Posted
July 25, 2013
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Severity of postcraniotomy headache within supra- and infratentorial sub-groups.
Changes from Baseline in Visual Analog Scale assessed at the first and fifth postoperative day
Analgesic need during the first five postoperative days.
Participants were followed for 5 days postoperatively
Postoperative complications during the first five postoperative days
Participants were followed for 5 days postoperatively
Intraoperative fentanyl use
Participants were followed during the operation on day 1.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Quiney N, Cooper R, Stoneham M, Walters F. Pain after craniotomy. A time for reappraisal? Br J Neurosurg. 1996 Jun;10(3):295-9. doi: 10.1080/02688699650040179.
Thibault M, Girard F, Moumdjian R, Chouinard P, Boudreault D, Ruel M. Craniotomy site influences postoperative pain following neurosurgical procedures: a retrospective study. Can J Anaesth. 2007 Jul;54(7):544-8. doi: 10.1007/BF03022318.
Nguyen A, Girard F, Boudreault D, Fugere F, Ruel M, Moumdjian R, Bouthilier A, Caron JL, Bojanowski MW, Girard DC. Scalp nerve blocks decrease the severity of pain after craniotomy. Anesth Analg. 2001 Nov;93(5):1272-6. doi: 10.1097/00000539-200111000-00048.
Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
Gottschalk A, Yaster M. The perioperative management of pain from intracranial surgery. Neurocrit Care. 2009;10(3):387-402. doi: 10.1007/s12028-008-9150-3. Epub 2008 Oct 1.
Roberts GC. Post-craniotomy analgesia: current practices in British neurosurgical centres--a survey of post-craniotomy analgesic practices. Eur J Anaesthesiol. 2005 May;22(5):328-32. doi: 10.1017/s0265021505000554.
de Gray LC, Matta BF. Acute and chronic pain following craniotomy: a review. Anaesthesia. 2005 Jul;60(7):693-704. doi: 10.1111/j.1365-2044.2005.03997.x.
Umamaheswara Rao GS, Gelb AW. To use or not to use: the dilemma of NSAIDs and craniotomy. Eur J Anaesthesiol. 2009 Aug;26(8):625-6. doi: 10.1097/EJA.0b013e32832a21ad. No abstract available.
Schug SA, Manopas A. Update on the role of non-opioids for postoperative pain treatment. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):15-30. doi: 10.1016/j.bpa.2006.12.002.
Primary Completion
April 2013
Actual (reported)Study Completion
April 2013
Actual (reported)Last Updated
July 25, 2013
Record last verified: 2013-07
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