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Clinical Trials/NCT01576601
NCT01576601
Completed
Not Applicable

The Management of Postoperative Craniotomy Pain in Pediatric Patients: A Prospective Cohort Study

Johns Hopkins University3 sites in 1 country81 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Craniotomy Surgery
Sponsor
Johns Hopkins University
Enrollment
81
Locations
3
Primary Endpoint
pain assessment
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
June 2013
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

pain assessment

Time Frame: 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 Outcomes

  • patient/parent satisfaction(2 years)

Study Sites (3)

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