Incidence of Pain After Craniotomy in Children (Brainpain)

San Gerardo Hospital

Status: Completed

Conditions: Disruption or Dehiscence of Closure of Skull or Craniotomy

Study type: Observational

Funder types: Other

Identifiers

NCT01142830

AR-HSG 01-2009

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 1 month to 10 years old

Volunteers: No Healthy Volunteers

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