Incidence of Pain After Craniotomy in Children

Completed

• Conditions: Disruption or Dehiscence of Closure of Skull or Craniotomy

• Registration Number: NCT01142830
• Lead Sponsor: San Gerardo Hospital

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 associated with significant pain following paediatric neurosurgery .

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2011-10
• Study Completion: 2012-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	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 Outcome Measures

Name	Time	Method
Analgesic Drugs	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	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	48 hs after surgery	* Continuous infusion; * PCA: Patients Controlled Analgesia; * Nurse controlled analgesia; * IV intermittent bolus; * Enteral intermittent: Oral, rectal; * Other (transdermal, etc.)

Trial Locations

Locations (8)

Ospedale Riuniti; 🇮🇹 Bergamo, Italy

Policlinico Universitario; 🇮🇹 Catania, Italy

Istituto Nazionale Neurologico "Carlo Besta"; 🇮🇹 Milano, Italy

Meyer Hospital; 🇮🇹 Firenze, Italy

Ospedale pediatrico Gaslini; 🇮🇹 Genova, Italy

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, Italy

Ospedale Infantile Regina Margherita; 🇮🇹 Torino, Italy