Status:
COMPLETED
Incidence of Pain After Craniotomy in Children
Lead Sponsor:
San Gerardo Hospital
Collaborating Sponsors:
University of Milano Bicocca
Royal Children's Hospital
Conditions:
Disruption or Dehiscence of Closure of Skull or Craniotomy
Eligibility:
All Genders
1-10 years
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- Emergency surgery for multiple trauma.
- Children requiring muscular relaxants during the postoperative period
- Children whose parents (or legal tutors) denied their own consensus
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01142830
Start Date
March 1 2009
End Date
December 1 2012
Last Update
February 25 2013
Active Locations (8)
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1
Ospedale Riuniti
Bergamo, Italy
2
Policlinico Universitario
Catania, Italy
3
Meyer Hospital
Florence, Italy
4
Ospedale pediatrico Gaslini
Genova, Italy