The Management of Postoperative Craniotomy Pain in Pediatric Patients
7. december 2017 opdateret af: Johns Hopkins University
The Management of Postoperative Craniotomy Pain in Pediatric Patients: A Prospective Cohort Study
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.
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
81
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Children's Hospital Boston
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Children's Hospital of Philadelphia
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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).
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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pain assessment
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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patient/parent satisfaction
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. august 2011
Primær færdiggørelse (Faktiske)
1. juni 2013
Studieafslutning (Faktiske)
1. juni 2013
Datoer for studieregistrering
Først indsendt
10. april 2012
Først indsendt, der opfyldte QC-kriterier
11. april 2012
Først opslået (Skøn)
12. april 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. december 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. december 2017
Sidst verificeret
1. december 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NA_00051171
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .