- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01576601
The Management of Postoperative Craniotomy Pain in Pediatric Patients
The Management of Postoperative Craniotomy Pain in Pediatric Patients: A Prospective Cohort Study
Studie Overzicht
Toestand
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Maryland
-
Baltimore, Maryland, Verenigde Staten, 21287
- Johns Hopkins Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02115
- Children's Hospital Boston
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Children's Hospital of Philadelphia
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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).
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
---|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
pain assessment
Tijdsspanne: 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.
|
2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
patient/parent satisfaction
Tijdsspanne: 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.
|
2 years
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- NA_00051171
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .