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Incidence of Pain After Craniotomy in Children (Brainpain)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01142830
First Posted: June 11, 2010
Last Update Posted: February 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Milano Bicocca
Royal Children's Hospital
Policlinico Universitario, Catania
Istituto Giannina Gaslini
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Policlinico Universitario Agostino Gemelli
Ospedale Meyer
Ospedale Civile, Padova. Italy
A.O. Ospedale Papa Giovanni XXIII
Information provided by (Responsible Party):
Pablo Mauricio Ingelmo M.D., San Gerardo Hospital
June 9, 2010
June 11, 2010
February 25, 2013
March 2009
October 2011   (Final data collection date for primary outcome measure)
Postoperative Pain [ Time Frame: 48 hs after surgery ]

Pain at rest and in activity will be evaluated using one or more of the following instruments:

  • FLACC scale for non ventilated children from 1month to 6 years of age or non ventilated children of all ages not could not be evaluated with the Numeric Rating Scale (NRS) (a ≥4 score is considered pain)
  • Numeric Rating Scale (NRS) for non ventilated children from 7 to 10 years of age (a ≥ 4 score is considered pain)
  • COMFORT scale for ventilated children from 1month to 10 years of age (a ≥ 27 score is considered distress)
Same as current
Complete list of historical versions of study NCT01142830 on ClinicalTrials.gov Archive Site
  • Analgesic Drugs [ Time Frame: 48 hs after surgery ]

    1. Type and dose of analgesic therapy used including intra operative administration

    • Local anesthetic infiltration (dose and time related to surgery)
    • Scalp block (dose and time related to surgery)
    • Paracetamol
    • NSAID
    • Weak opioids (i.e. codeine, tramadol)
    • Strong opioids (i.e. morphine, fentanyl)
    • Other drugs including ketamine, clonidine
  • Complication of analgesic therapy [ Time Frame: 48 hs after surgery ]
    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
  • Methods of administration of analgesic drugs [ Time Frame: 48 hs after surgery ]
    • Continuous infusion
    • PCA: Patients Controlled Analgesia
    • Nurse controlled analgesia
    • IV intermittent bolus
    • Enteral intermittent: Oral, rectal
    • Other (transdermal, etc.)
Same as current
Not Provided
Not Provided
 
Incidence of Pain After Craniotomy in Children
Prospective Multicenter Cohort Study Evaluating Incidence and Intensity of Postoperative Pain in Pediatric Patients After Craniotomy

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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
Disruption or Dehiscence of Closure of Skull or Craniotomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
December 2012
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Month to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01142830
AR-HSG 01-2009
No
Not Provided
Not Provided
Pablo Mauricio Ingelmo M.D., San Gerardo Hospital
San Gerardo Hospital
  • University of Milano Bicocca
  • Royal Children's Hospital
  • Policlinico Universitario, Catania
  • Istituto Giannina Gaslini
  • Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
  • Policlinico Universitario Agostino Gemelli
  • Ospedale Meyer
  • Ospedale Civile, Padova. Italy
  • A.O. Ospedale Papa Giovanni XXIII
Principal Investigator: Pablo M. Ingelmo, MD San Gerardo Hospital
Study Chair: Marta Somaini, MD San Gerardo Hospital
San Gerardo Hospital
February 2013