The Management of Postoperative Craniotomy Pain in Pediatric Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Myron Yaster, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01576601
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.


Condition
Post Craniotomy Surgery
Cancer
Epilepsy
Vascular Malformations
Craniofacial Reconstructive Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Management of Postoperative Craniotomy Pain in Pediatric Patients: A Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • pain assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • patient/parent satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hopkins
Pediatric patients (0-18 yo) who are scheduled for craniotomy surgery under general anesthesia. This will include patients undergoing brain surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstructive surgery. Patients will receive routine postoperative management and treated for pain based on institutional routine. We will follow patients for the first 5 post-operative days or until discharge, whichever comes first.
Childrens Hospital of Philadelphia
Pediatric patients (0-18 yo) who are scheduled for craniotomy surgery under general anesthesia. This will include patients undergoing brain surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstructive surgery. Patients will receive routine postoperative management and treated for pain based on institutional routine. We will follow patients for the first 5 post-operative days or until discharge, whichever comes first.
Childrens Hospital Boston
Pediatric patients (0-18 yo) who are scheduled for craniotomy surgery under general anesthesia. This will include patients undergoing brain surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstructive surgery. Patients will receive routine postoperative management and treated for pain based on institutional routine. We will follow patients for the first 5 post-operative days or until discharge, whichever comes first.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

200 patients who are scheduled for craniotomy surgery under general anesthesia at 3 major children's hospitals will be eligible. Potential patients include those undergoing brain surgery for cancer, epilepsy, vascular malformations, and craniofacial reconstructive surgery. Following surgery, patients will receive routine postoperative management and treated for pain based on institutional routine. We will follow patients for the first 5 post-operative days or until discharge, whichever comes first.

Once daily, a study investigator will make an independent pain assessment using an age appropriate, validated tool (FLACC, Pain Face Scale-Revised, self report on a 0-10 scale). The study investigator will also assess overall quality of life and patient/parent satisfaction using a subset of the NRC Picker satisfaction tool and in adolescents a modified QoR-40 (see below).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576601

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Johns Hopkins University
  More Information

Publications:
Responsible Party: Myron Yaster, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01576601     History of Changes
Other Study ID Numbers: NA_00051171
Study First Received: April 10, 2012
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
pediatrics
acute pain
neurosurgery
Pediatric patients (0-18)
postoperative management

Additional relevant MeSH terms:
Congenital Abnormalities
Epilepsy
Vascular Malformations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014