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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
Sponsor:
Information provided by (Responsible Party):
Tamas Vegh, MD, University of Debrecen

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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.
Drug: Diclofenac
Other Names:
  • DICLOFENAC-ratiopharm
  • Voltaren
  • DICLOFENAC-STADA

Drug: Midazolam
Other Name: Dormicum

Active Comparator: Midazolam
Midazolam 7.5 g tablet was administered as premedication by mouth 30 minutes before surgical interventions.
Drug: Midazolam
Other Name: Dormicum




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907984


Locations
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Hungary
University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, Hungary, 4032
Sponsors and Collaborators
University of Debrecen
Investigators
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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

Publications:

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Responsible Party: Tamas Vegh, MD, assistant lecturer anesthesiologist and intensive care specialist, University of Debrecen
ClinicalTrials.gov Identifier: NCT01907984     History of Changes
Other Study ID Numbers: 5481-1/2013/EKU
DEOEC RKEB/IKEB:3769-2012 ( Other Identifier: University of Debrecen,RKEB/IKEB )
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013
Keywords provided by Tamas Vegh, MD, University of Debrecen:
premedication
diclofenac
postoperative headache
Visual Analog Scale
Additional relevant MeSH terms:
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Diclofenac
Headache
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors