The Management of Postoperative Craniotomy Pain in Pediatric Patients

Completed

• Conditions: Vascular Malformations; Craniofacial Reconstructive Surgery; Epilepsy; Post Craniotomy Surgery; Cancer

• Registration Number: NCT01576601
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this prospective, clinical observational trial is to assess the incidence of pain (and analgesia), methods of pain assessment (and by whom), prescribed analgesics, methods of analgesic delivery, and patient/parent satisfaction in patients undergoing craniotomy surgery at three major children's hospitals (Boston Children's Hospital, Children's Hospital of Philadelphia, The Children's Center Johns Hopkins Hospital) in the United States.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Pediatric patients 0-18 years, who are scheduled to undergo craniotomy surgery for any reason (e.g., brain tumor, epilepsy surgery, craniofacial reconstruction) at either the Boston Children's Hospital, the Children's Hospital of Philadelphia, or the Children's Center of the Johns Hopkins Hospital will be eligible for enrollment.

Exclusion Criteria

• Patients who remain intubated after surgery. Additionally, we will exclude patients who are allergic to opioids or who have a history of substance abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain assessment	2 years	To determine the severity of pain and the compliance of physicians and nurses in implementation of institutionally mandated pain assessment tools by chart review. We will also assess which pain assessment tools are in use by health care providers in the 3 participating institutions along with compliance with frequency of pain assessment based on institutional policy.

Secondary Outcome Measures

Name	Time	Method
patient/parent satisfaction	2 years	To independently determine patient/parent satisfaction and quality of recovery (QOR). Daily, an investigator will use a validated, standardized parental satisfaction tool (a subset of the NRC Picker satisfaction tool) and in adolescents a modified QoR-40.

Trial Locations

Locations (3)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States