Postcraniotomy HeadachePhase 4NCT01907984
Diclofenac Administered Before Skull Operations Reduces the Severity of Headache After the Intervention
A Phase 4 study testing Diclofenac and Midazolam in people with Postcraniotomy Headache and Intraoperative Analgesic Use, run by University of Debrecen at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postcraniotomy Headache, Intraoperative Analgesic Use, Postoperative Analgesic Use
- What is being tested?
- Diclofenac and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHungary
- Study dates
- Dec 2012to Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
University of Debrecen Medical and Health Science Center Department of Anesthesiology and Intensive Care
Debrecen, Hajdú-Bihar, 4032
About this study
Official title: Preoperatively Administered Single Dose Diclofenac Reduces the Intensity of Acute Postcraniotomy Headache and Decreases Postoperative Analgesic Requirements- a Randomized, Controlled Trial
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.
Read more
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.
Read the detailed description
Before surgery, every patient's previous history was taken routinely and along with this, special attention was paid to a history of preoperative headache, its severity and any analgesics used regularly prior to surgery. In this study 200 cooperative adults (over 18 years) undergoing elective craniotomy were randomly assigned into two groups with: 100 patients received 7.5 mg midazolam and 100 mg diclofenac as premedication, while the other 100 members of the control group received only 7.5 mg midazolam one hour prior to surgery. Envelop randomization was used to schedule patients to diclofenac or to placebo groups. Neither the anesthetists, nor the physician obtaining the postoperative VAS scores were aware of the actual patient's grouping (diclofenac or placebo) during the entire study. For induction of anesthesia, we used propofol (1-2,5 mg/kgBW), whereas for maintenance of anesthesia we used the combination of fentanyl, rocuronium, and sevoflurane. Craniotomy and opening the dura occurred always after the tissue saturation of sevoflurane and low-flow anesthetic technique was applied at a sevoflurane concentration ranging from 1.2 to 2.1 V% as required for maintenance of adequate anesthesia. Fentanyl was administered as an initial bolus of 100-150 µg followed by a maintenance dose of 2 µg/kgBW/h. The total dose of fentanyl was calculated offline after the procedure in all cases. The surgical site was infiltrated by a combination of 2% lidocaine and epinephrine in all cases. All patients were admitted to the neurosurgical ICU for postoperative observation. A stepwise analgesic regimen was decided prior the study. Severity of pain was assessed regularly by the ICU nurses and additional analgesics were used if the patient complained a headache severity of VAS >3. In these cases additional paracetamol (1-2 g given intravenously) was administered. If this was not effective, an additional dose of 100 mg diclofenac was given to the patients. In case of further ineffectivity, tramadol was administered in a dose of 100 mg per os or iv. At the end of the study the cumulative dose of analgesics that was administered to the patients was calculated. For sake of clarity we transformed analgesic doses to equianalgetic doses of intramuscular morphine according to the table of the Oxford Pain Site and these values were used for further comparisons of analgesic requirements.
Pain assessment occurred at bedrest state by using a 0-10 scaled visual analogue scale (VAS). Assessment of actual VAS scores was regularly performed by the nurses of the neurosurgical ICU during days 1-5 and rescue analgesics were given according to the actual needs of the patients. An independent physician (who was unaware of randomization) performed an additional check of VAS scores by asking the patient, what was her/his worse pain during the day. As the patient's satisfaction was considered to be dependent on the worse pain, only these VAS scores were used for further analysis.
The investigators intended to answer the following study questions:
- Our research intended to examine whether 100 mg preoperatively give diclofenac reduces the incidence and severity of PCH on the first and fifth postoperative days.
- Is there a difference in the incidence and severity of PCH between patients who underwent infra- or supratentorial interventions?
- Does 100 mg preoperatively give diclofenac reduce intraoperative and postoperative analgesic needs?
- Does 100 mg preoperatively give diclofenac increase the incidence of postoperative hemorrhagic events?
Grouping of the patients:
The anesthesiologist on duty assigned the participants randomly to the control or to the diclofenac group by using envelope randomization technique the day before the surgery.
Members of the control group received 7.5 mg midazolam, while members of the diclofenac group received 7.5 mg midazolam and 100 mg diclofenac for premedication.
Gathering data:
Since no objective method exist to measure pain patients were asked to rate their headache subjectively with the help of a visual analog scale, where 0 stands for no pain and 10 for intolerable pain. In order to make the interpretation of data easier the scale was divided into three parts: between 1 and 3 the headache is mild, from 4 to 6 it is moderate, while 7 or a greater value represents a particularly strong pain.
The sites of the surgical intervention, intra- and postoperative analgesic needs, postoperative complications were recorded individually onto a personal data sheet.
Each data mentioned above was registered by a third pre-trained, independent (blind) member of the study team, who was unaware of the premedication and grouping of patients.
Statistical methods:
Statistical analysis was performed using Statistica for Windows (Statsoft, Tulsa, USA) statistical program. A normality test revealed that data of VAS scores and analgesic requirements show non-normal distribution, therefore a non-parametric Mann-Whitney test was used for further comparisons. A p-value of <0.05 was accepted as statistically significant during analysis.
- Conditions
- Postcraniotomy Headache, Intraoperative Analgesic Use, Postoperative Analgesic Use, Postoperative Complications
- Being tested
- Diclofenac, Midazolam
- Keywords
- premedication, diclofenac, postoperative headache, Visual Analog Scale
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Also called DICLOFENAC-ratiopharm, Voltaren, DICLOFENAC-STADA
MidazolamDrug
Also called Dormicum
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Diclofenac; Drug: Midazolam |
| Midazolam | Active comparator | Midazolam 7.5 g tablet was administered as premedication by mouth 30 minutes before surgical interventions. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: Changes from Baseline in Visual Analog Scale assessed at the first and fifth postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postcraniotomy HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamas Vegh, MD, University of Debrecen
- Investigators
- Csilla Molnár, MD, PhD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907984
- Sponsor's protocol ID
- 5481-1/2013/EKU
- Other IDs
- DEOEC RKEB/IKEB:3769-2012
- Status last verified
- Jul 2013
- First submitted
- 11 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8837797Rocha-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.
PubMed 17986272Quiney 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.
PubMed 8799542Thibault 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.
PubMed 17602040Nguyen 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.
PubMed 11682413Gottschalk 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.
PubMed 17410701Gottschalk 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.
PubMed 18830699Roberts 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.
PubMed 15918378de 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.
PubMed 15960721Umamaheswara 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.
PubMed 19584610Schug 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.
PubMed 17489217
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperatively Administered Single Dose Diclofenac Reduces the Intensity of Acute Postcraniotomy Headache and Decreases Postoperative Analgesic Requirements- a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01907984
- Acronym / sponsor ID
- 5481-1/2013/EKU
- Conditions
- Postcraniotomy Headache, Intraoperative Analgesic Use, Postoperative Analgesic Use, Postoperative Complications
- Keywords
- premedication, diclofenac, postoperative headache, Visual Analog Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Before surgery, every patient's previous history was taken routinely and along with this, special attention was paid to a history of preoperative headache, its severity and any analgesics used regularly prior to surgery. In this study 200 cooperative adults (over 18 years) undergoing elective craniotomy were randomly assigned into two groups with: 100 patients received 7.5 mg midazolam and 100 mg diclofenac as premedication, while the other 100 members of the control group received only 7.5 mg midazolam one hour prior to surgery. Envelop randomization was used to schedule patients to diclofenac or to placebo groups. Neither the anesthetists, nor the physician obtaining the postoperative VAS scores were aware of the actual patient's grouping (diclofenac or placebo) during the entire study. For induction of anesthesia, we used propofol (1-2,5 mg/kgBW), whereas for maintenance of anesthesia we used the combination of fentanyl, rocuronium, and sevoflurane. Craniotomy and opening the dura occurred always after the tissue saturation of sevoflurane and low-flow anesthetic technique was applied at a sevoflurane concentration ranging from 1.2 to 2.1 V% as required for maintenance of adequate anesthesia. Fentanyl was administered as an initial bolus of 100-150 µg followed by a maintenance dose of 2 µg/kgBW/h. The total dose of fentanyl was calculated offline after the procedure in all cases. The surgical site was infiltrated by a combination of 2% lidocaine and epinephrine in all cases. All patients were admitted to the neurosurgical ICU for postoperative observation. A stepwise analgesic regimen was decided prior the study. Severity of pain was assessed regularly by the ICU nurses and additional analgesics were used if the patient complained a headache severity of VAS >3. In these cases additional paracetamol (1-2 g given intravenously) was administered. If this was not effective, an additional dose of 100 mg diclofenac was given to the patients. In case of further ineffectivity, tramadol was administered in a dose of 100 mg per os or iv. At the end of the study the cumulative dose of analgesics that was administered to the patients was calculated. For sake of clarity we transformed analgesic doses to equianalgetic doses of intramuscular morphine according to the table of the Oxford Pain Site and these values were used for further comparisons of analgesic requirements.
Pain assessment occurred at bedrest state by using a 0-10 scaled visual analogue scale (VAS). Assessment of actual VAS scores was regularly performed by the nurses of the neurosurgical ICU during days 1-5 and rescue analgesics were given according to the actual needs of the patients. An independent physician (who was unaware of randomization) performed an additional check of VAS scores by asking the patient, what was her/his worse pain during the day. As the patient's satisfaction was considered to be dependent on the worse pain, only these VAS scores were used for further analysis.
The investigators intended to answer the following study questions:
- Our research intended to examine whether 100 mg preoperatively give diclofenac reduces the incidence and severity of PCH on the first and fifth postoperative days.
- Is there a difference in the incidence and severity of PCH between patients who underwent infra- or supratentorial interventions?
- Does 100 mg preoperatively give diclofenac reduce intraoperative and postoperative analgesic needs?
- Does 100 mg preoperatively give diclofenac increase the incidence of postoperative hemorrhagic events?
Grouping of the patients:
The anesthesiologist on duty assigned the participants randomly to the control or to the diclofenac group by using envelope randomization technique the day before the surgery.
Members of the control group received 7.5 mg midazolam, while members of the diclofenac group received 7.5 mg midazolam and 100 mg diclofenac for premedication.
Gathering data:
Since no objective method exist to measure pain patients were asked to rate their headache subjectively with the help of a visual analog scale, where 0 stands for no pain and 10 for intolerable pain. In order to make the interpretation of data easier the scale was divided into three parts: between 1 and 3 the headache is mild, from 4 to 6 it is moderate, while 7 or a greater value represents a particularly strong pain.
The sites of the surgical intervention, intra- and postoperative analgesic needs, postoperative complications were recorded individually onto a personal data sheet.
Each data mentioned above was registered by a third pre-trained, independent (blind) member of the study team, who was unaware of the premedication and grouping of patients.
Statistical methods:
Statistical analysis was performed using Statistica for Windows (Statsoft, Tulsa, USA) statistical program. A normality test revealed that data of VAS scores and analgesic requirements show non-normal distribution, therefore a non-parametric Mann-Whitney test was used for further comparisons. A p-value of <0.05 was accepted as statistically significant during analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac and Midazolam | Experimental | Drug: Diclofenac, Drug: MidazolamDiclofenac 100 mg tablet and Midazolam 7.5 mg tablet were administered by mouth as premedication 30 minutes before surgical interventions. |
| Midazolam | Active comparator | Drug: MidazolamMidazolam 7.5 g tablet was administered as premedication by mouth 30 minutes before surgical interventions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiclofenacAlso: DICLOFENAC-ratiopharm, Voltaren, DICLOFENAC-STADA | Drug | Diclofenac and Midazolam |
| MidazolamAlso: Dormicum | Drug | Diclofenac and Midazolam, Midazolam |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Background: PubMed 8837797De 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.
- Background: PubMed 17986272Rocha-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.
- Background: PubMed 8799542Quiney 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.
- Background: PubMed 17602040Thibault 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.
- Background: PubMed 11682413Nguyen 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.
- Background: PubMed 17410701Gottschalk 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.
- Background: PubMed 18830699Gottschalk 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.
- Background: PubMed 15918378Roberts 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.
- Background: PubMed 15960721de 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.
- Background: PubMed 19584610Umamaheswara 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.
- Background: PubMed 17489217Schug 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Csilla Molnár, MD, PhD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac and Midazolam in people with Postcraniotomy Headache and Intraoperative Analgesic Use, run by University of Debrecen at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01907984, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.