Incidence of Pain After Craniotomy in Children

San Gerardo Hospital218 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

218

Conditions

Disruption or Dehiscence of Closure of Skull or Craniotomy

Eligibility

Sex: ALLMin age: 1 MonthMax age: 10 Years

Medical Language ↔ Plain English

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

Locations (8)

Ospedale Riuniti

Bergamo, Italy

Policlinico Universitario

Catania, Italy

Meyer Hospital

Florence, Italy

Ospedale pediatrico Gaslini

Genova, Italy

Outcomes

Primary Outcomes

Postoperative Pain

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)

Time frame: 48 hs after surgery

Secondary Outcomes

Analgesic Drugs

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

Time frame: 48 hs after surgery

Complication of analgesic therapy

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

Time frame: 48 hs after surgery

Methods of administration of analgesic drugs

* Continuous infusion * PCA: Patients Controlled Analgesia * Nurse controlled analgesia * IV intermittent bolus * Enteral intermittent: Oral, rectal * Other (transdermal, etc.)

Time frame: 48 hs after surgery

Data from ClinicalTrials.gov

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