The Management of Postoperative Craniotomy Pain in Pediatric Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Post Craniotomy Surgery, Cancer, Epilepsy, Vascular Malformations, Craniofacial Reconstructive Surgery

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hopkins<br>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<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain assessment | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient/parent satisfaction | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, acute pain, neurosurgery, Pediatric patients (0-18), postoperative management