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| Name | Class |
|---|---|
| University of Milano Bicocca | OTHER |
| Royal Children's Hospital | OTHER |
| Policlinico Universitario, Catania | OTHER |
| Istituto Giannina Gaslini |
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The primary objective is to assess the incidence and severity of pain after major craniotomy in paediatric patients (from 1 month to 10 years of age).
The secondary objective is to determine factors associated with significant pain following paediatric neurosurgery .
Research in the adult population has evaluated incidence and severity of post-neurosurgical pain, and effectiveness of different post-neurosurgical analgesic regimens. Several small studies report the prevalence of some period of moderate to severe pain in the first 24 postoperative hours to be from 41 to 84 % of patients. In a prospective single academic medical institution study, adult patients treated with only acetaminophen and modest amounts of opioids on an as needed basis reported moderate to severe pain for the first 2 days after surgery. These findings have supported a growing consensus that perioperative pain associated with intracranial surgery may be more significant than initially appreciated. Factors that have been associated with increased pain after intracranial surgery include sex, younger age, surgical site, and surgical approach to the site. Pain may also be a significant factor in the quality of recovery from intracranial surgery. In contrast there are few studies describing the incidence or management of pain after neurosurgery in children.
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Pain at rest and in activity will be evaluated using one or more of the following instruments:
| 48 hs after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Drugs | 1. Type and dose of analgesic therapy used including intra operative administration
| 48 hs after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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330 paediatric patients undergoing major craniotomy from the following Italian Hospitals: Policlinico Universitario Catania Ospedale Gaslini, Genova Ospedale Regina Margherita, Torino Ospedale Gemelli, Roma Ospedale Meyer, Firenze Ospedale Civile di Padova Ospedale Riuniti di Bergamo Ospedale San Gerardo di Monza
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| Name | Affiliation | Role |
|---|---|---|
| Pablo M. Ingelmo, MD | San Gerardo Hospital | Principal Investigator |
| Marta Somaini, MD | San Gerardo Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Riuniti | Bergamo | Italy | ||||
| Policlinico Universitario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15960721 | 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. | |
| 8799542 | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
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| Complication of analgesic therapy | Complications that might be associated with analgesic therapy and could conceivably affect recovery from intracranial surgery, such as postoperative nausea and vomiting, excessive sedation, and respiratory depression will be considered and registered in the collecting data form | 48 hs after surgery |
| Methods of administration of analgesic drugs |
| 48 hs after surgery |
| Catania |
| Italy |
| Meyer Hospital | Florence | Italy |
| Ospedale pediatrico Gaslini | Genova | Italy |
| Istituto Nazionale Neurologico "Carlo Besta" | Milan | Italy |
| Azienda Ospedaliera di Padova | Padova | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | Italy |
| Ospedale Infantile Regina Margherita | Torino | Italy |
| 14625709 | Background | 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. |
| 8837797 | Background | 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. |
| 16572646 | Background | 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. |
| 17410701 | 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. |
| 11275389 | Background | 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. |
| 10667820 | Background | 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. |
| 14576554 | Background | 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. |
| 24467608 | Derived | 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. |