Clinical trial NCT01142830: Incidence of Pain After Craniotomy in Children
Official title: Prospective Multicenter Cohort Study Evaluating Incidence and Intensity of Postoperative Pain in Pediatric Patients After Craniotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disruption or Dehiscence of Closure of Skull or Craniotomy
Keywords: Craniotomy
Pain
Children
Lead sponsor: San Gerardo Hospital
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
name: Royal Children's Hospital
name: Policlinico Universitario, Catania
name: Istituto Giannina Gaslini
name: Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Ospedale Meyer
name: Ospedale Civile, Padova. Italy
name: A.O. Ospedale Papa Giovanni XXIII
First posted: 2010-06-11
Enrollment: 218
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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 .

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male and Female children from 1 month to 10 years Of age
* 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:

* Emergency surgery for multiple trauma.
* Children requiring muscular relaxants during the postoperative period
* Children whose parents (or legal tutors) denied their own consensus

Primary outcomes:
measure: Postoperative Pain
timeFrame: 48 hs after surgery
Secondary outcomes:
measure: Analgesic Drugs
timeFrame: 48 hs after surgery
measure: Complication of analgesic therapy
timeFrame: 48 hs after surgery
measure: Methods of administration of analgesic drugs
timeFrame: 48 hs after surgery
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedale Riuniti
city: Catania
country: Italy
facility: Policlinico Universitario
city: Firenze
country: Italy
facility: Meyer Hospital
city: Genova
country: Italy
facility: Ospedale pediatrico Gaslini
city: Milano
country: Italy
facility: Istituto Nazionale Neurologico "Carlo Besta"
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Torino
country: Italy
facility: Ospedale Infantile Regina Margherita
Study officials:
affiliation: San Gerardo Hospital
name: Pablo M. Ingelmo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Gerardo Hospital
name: Marta Somaini, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.