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NCT Number: NCT01142830

Incidence of Pain After Craniotomy in Children

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 .

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Key information

Conditions

Disruption or Dehiscence of Closure of Skull or Craniotomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 month–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Riuniti, Bergamo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Analgesic Drugs

    Time frame: 48 hs after surgery

    • 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

  2. 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

  3. 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.)

Sponsors and collaborators

Lead sponsor

San Gerardo Hospital

Other

Collaborators

  • A.O. Ospedale Papa Giovanni XXIII
  • Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Istituto Giannina Gaslini
  • Ospedale Civile, Padova. Italy
  • Ospedale Meyer
  • Policlinico Universitario, Catania
  • Royal Children's Hospital
  • University of Milano Bicocca

Registry information

Official study title

Prospective Multicenter Cohort Study Evaluating Incidence and Intensity of Postoperative Pain in Pediatric Patients After Craniotomy

Acronym: Brainpain

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 11, 2010
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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