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

NCT01907984 | Completed Phase 4

• 2 other identifiers: 5481-1/2013/EKUDEOEC RKEB/IKEB:3769-2012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postcraniotomy Headache; Intraoperative Analgesic Use; Postoperative Analgesic Use; Postoperative Complications

Keywords

premedication; diclofenac; postoperative headache; Visual Analog Scale

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• 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

Other Outcomes (3)

• 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.

Study Arms (2)

Diclofenac and Midazolam

EXPERIMENTAL

Diclofenac 100 mg tablet and Midazolam 7.5 mg tablet were administered by mouth as premedication 30 minutes before surgical interventions.

Drug: Diclofenac; Drug: Midazolam

Midazolam

ACTIVE COMPARATOR

Midazolam 7.5 g tablet was administered as premedication by mouth 30 minutes before surgical interventions.

Drug: Midazolam

Interventions

Diclofenac DRUG

Also known as: DICLOFENAC-ratiopharm, Voltaren, DICLOFENAC-STADA

Diclofenac and Midazolam

Midazolam DRUG

Also known as: Dormicum

Diclofenac and Midazolam; Midazolam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Related Publications (11)

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  PMID: 8837797 BACKGROUND

• 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.

  PMID: 17986272 BACKGROUND

• 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.

  PMID: 8799542 BACKGROUND

• 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.

  PMID: 17602040 BACKGROUND

• 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.

  PMID: 11682413 BACKGROUND

• 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.

  PMID: 17410701 BACKGROUND

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  PMID: 18830699 BACKGROUND

• 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.

  PMID: 15918378 BACKGROUND

• 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.

  PMID: 15960721 BACKGROUND

• 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.

  PMID: 19584610 BACKGROUND

• 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.

  PMID: 17489217 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Diclofenac; Midazolam

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer anesthesiologist and intensive care specialist

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 25, 2013
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

HU (1)