Incidence of Pain After Craniotomy in Children (Brainpain)

This study has been completed.
Sponsor:
Collaborators:
University of Milano Bicocca
Royal Children's Hospital
Policlinico Universitario, Catania. Italy
Istituto Giannina Gaslini
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Policlinico Universitario Agostino Gemelli, Roma. Italy
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
ClinicalTrials.gov Identifier:
NCT01142830
First received: June 9, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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 .


Condition
Disruption or Dehiscence of Closure of Skull or Craniotomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicenter Cohort Study Evaluating Incidence and Intensity of Postoperative Pain in Pediatric Patients After Craniotomy

Further study details as provided by San Gerardo Hospital:

Primary Outcome Measures:
  • Postoperative Pain [ Time Frame: 48 hs after surgery ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Analgesic Drugs [ Time Frame: 48 hs after surgery ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    • Continuous infusion
    • PCA: Patients Controlled Analgesia
    • Nurse controlled analgesia
    • IV intermittent bolus
    • Enteral intermittent: Oral, rectal
    • Other (transdermal, etc.)


Enrollment: 218
Study Start Date: March 2009
Study Completion Date: December 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   1 Month to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142830

Locations
Italy
Ospedale Riuniti
Bergamo, Italy
Policlinico Universitario
Catania, Italy
Meyer Hospital
Firenze, Italy
Ospedale pediatrico Gaslini
Genova, Italy
Istituto Nazionale Neurologico "Carlo Besta"
Milano, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Policlinico Universitario Agostino Gemelli
Rome, Italy
Ospedale Infantile Regina Margherita
Torino, Italy
Sponsors and Collaborators
San Gerardo Hospital
University of Milano Bicocca
Royal Children's Hospital
Policlinico Universitario, Catania. Italy
Istituto Giannina Gaslini
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Policlinico Universitario Agostino Gemelli, Roma. Italy
Ospedale Meyer
Ospedale Civile, Padova. Italy
A.O. Ospedale Papa Giovanni XXIII
Investigators
Principal Investigator: Pablo M. Ingelmo, MD San Gerardo Hospital
Study Chair: Marta Somaini, MD San Gerardo Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pablo Mauricio Ingelmo M.D., Paediatric Anesthesia Coordinator, San Gerardo Hospital
ClinicalTrials.gov Identifier: NCT01142830     History of Changes
Other Study ID Numbers: AR-HSG 01-2009
Study First Received: June 9, 2010
Last Updated: February 22, 2013
Health Authority: Australia: Prof. Andrew Davidson. Murdoch Children's Research Institute; Melbourne

Keywords provided by San Gerardo Hospital:
Craniotomy
Pain
Children

ClinicalTrials.gov processed this record on August 01, 2014