Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
218 participants
OBSERVATIONAL
2009-03-31
2012-12-31
Brief Summary
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The secondary objective is to determine factors associated with significant pain following paediatric neurosurgery .
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* American Society of Anaesthesiologists Classification (ASA) I-III
* Scheduled for supratentorial or infratentorial craniotomy
* Admission to an Intensive Care Unit, Neurosurgery ward or paediatric ward of one of the hospitals included
* Children whose parents (or legal tutors) have given their informed written consent
Exclusion Criteria
* Children requiring muscular relaxants during the postoperative period
* Children whose parents (or legal tutors) denied their own consensus
1 Month
10 Years
ALL
No
Sponsors
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University of Milano Bicocca
OTHER
Royal Children's Hospital
OTHER
Policlinico Universitario, Catania
OTHER
Istituto Giannina Gaslini
OTHER
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Ospedale Meyer
OTHER
Ospedale Civile, Padova. Italy
UNKNOWN
A.O. Ospedale Papa Giovanni XXIII
OTHER
San Gerardo Hospital
OTHER
Responsible Party
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Pablo Mauricio Ingelmo M.D.
Paediatric Anesthesia Coordinator
Principal Investigators
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Pablo M. Ingelmo, MD
Role: PRINCIPAL_INVESTIGATOR
San Gerardo Hospital
Marta Somaini, MD
Role: STUDY_CHAIR
San Gerardo Hospital
Locations
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Ospedale Riuniti
Bergamo, , Italy
Policlinico Universitario
Catania, , Italy
Meyer Hospital
Florence, , Italy
Ospedale pediatrico Gaslini
Genova, , Italy
Istituto Nazionale Neurologico "Carlo Besta"
Milan, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Policlinico Universitario Agostino Gemelli
Rome, , Italy
Ospedale Infantile Regina Margherita
Torino, , Italy
Countries
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References
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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.
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.
Irefin SA, Schubert A, Bloomfield EL, DeBoer GE, Mascha EJ, Ebrahim ZY. The effect of craniotomy location on postoperative pain and nausea. J Anesth. 2003;17(4):227-31. doi: 10.1007/s00540-003-0182-8.
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.
Klimek M, Ubben JF, Ammann J, Borner U, Klein J, Verbrugge SJ. Pain in neurosurgically treated patients: a prospective observational study. J Neurosurg. 2006 Mar;104(3):350-9. doi: 10.3171/jns.2006.104.3.350.
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.
Jensen MP, Smith DG, Ehde DM, Robinsin LR. Pain site and the effects of amputation pain: further clarification of the meaning of mild, moderate, and severe pain. Pain. 2001 Apr;91(3):317-322. doi: 10.1016/S0304-3959(00)00459-0.
Koperer H, Deinsberger W, Jodicke A, Boker DK. Postoperative headache after the lateral suboccipital approach: craniotomy versus craniectomy. Minim Invasive Neurosurg. 1999 Dec;42(4):175-8. doi: 10.1055/s-2008-1053393.
Leslie K, Troedel S, Irwin K, Pearce F, Ugoni A, Gillies R, Pemberton E, Dharmage S. Quality of recovery from anesthesia in neurosurgical patients. Anesthesiology. 2003 Nov;99(5):1158-65. doi: 10.1097/00000542-200311000-00024.
Bronco A, Pietrini D, Lamperti M, Somaini M, Tosi F, del Lungo LM, Zeimantz E, Tumolo M, Lampugnani E, Astuto M, Perna F, Zadra N, Meneghini L, Benucci V, Bussolin L, Scolari A, Savioli A, Locatelli BG, Prussiani V, Cazzaniga M, Mazzoleni F, Giussani C, Rota M, Ferland CE, Ingelmo PM. Incidence of pain after craniotomy in children. Paediatr Anaesth. 2014 Jul;24(7):781-7. doi: 10.1111/pan.12351. Epub 2014 Jan 28.
Other Identifiers
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AR-HSG 01-2009
Identifier Type: -
Identifier Source: org_study_id
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