- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT01576601
The Management of Postoperative Craniotomy Pain in Pediatric Patients
The Management of Postoperative Craniotomy Pain in Pediatric Patients: A Prospective Cohort Study
Przegląd badań
Status
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Children's Hospital Boston
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Children's Hospital of Philadelphia
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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).
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
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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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
pain assessment
Ramy czasowe: 2 years
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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.
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2 years
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
patient/parent satisfaction
Ramy czasowe: 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.
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2 years
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.
- Morad A, Winters B, Stevens R, White E, Weingart J, Yaster M, Gottschalk A. The efficacy of intravenous patient-controlled analgesia after intracranial surgery of the posterior fossa: a prospective, randomized controlled trial. Anesth Analg. 2012 Feb;114(2):416-23. doi: 10.1213/ANE.0b013e31823f0c5a. Epub 2011 Dec 9.
- Morad AH, Winters BD, Yaster M, Stevens RD, White ED, Thompson RE, Weingart JD, Gottschalk A. Efficacy of intravenous patient-controlled analgesia after supratentorial intracranial surgery: a prospective randomized controlled trial. Clinical article. J Neurosurg. 2009 Aug;111(2):343-50. doi: 10.3171/2008.11.JNS08797.
- Maxwell LG, Buckley GM, Kudchadkar SR, Ely E, Stebbins EL, Dube C, Morad A, Jastaniah EA, Sethna NF, Yaster M. Pain management following major intracranial surgery in pediatric patients: a prospective cohort study in three academic children's hospitals. Paediatr Anaesth. 2014 Nov;24(11):1132-40. doi: 10.1111/pan.12489. Epub 2014 Jul 29.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NA_00051171
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