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The Management of Postoperative Craniotomy Pain in Pediatric Patients

Johns Hopkins University logo

Johns Hopkins University

Status

Completed

Conditions

Epilepsy
Post Craniotomy Surgery
Vascular Malformations
Craniofacial Reconstructive Surgery
Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT01576601
NA_00051171

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

81 participants in 3 patient groups

Hopkins
Description:
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
Description:
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
Description:
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.

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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