The Management of Postoperative Craniotomy Pain in Pediatric Patients

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.

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Key information

Conditions

Post Craniotomy Surgery Acute Pain Brain Diseases Cancer Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Reconstructive Surgery Epilepsy Neoplasms Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Malformations

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Apr 12, 2012
Registry last updated: Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed