Incidence of Pain After Craniotomy in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Disruption or Dehiscence of Closure of Skull or Craniotomy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 48 hs after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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.) | 48 hs after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniotomy, Pain, Children