NCT01142830

Incidence of Pain After Craniotomy in Children

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 218 (actual)
• Sponsor: San Gerardo Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disruption or Dehiscence of Closure of Skull or Craniotomy

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-10-01
• Completion: 2012-12-01
• First posted: 2010-06-11
• Last updated: 2013-02-25

Locations

8 sites across 1 country: Italy