Clinical TrialID 3531

Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients

NCT03894904

Pediatrics|Anesthesia|Vasospasm

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Record Fields

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Clinical Trial Id
3531
Evidence Id
3531
Core Evidence Id
3531
Source Clinical Trial Id
3504
Herb2 Clinical Trial Id
HBCT003504
Nct Id
NCT03894904
Title
Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients
Status
Completed
Phase
Phase 4
Study Result
Yes
Study Condition
Pediatrics|Anesthesia|Vasospasm
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION
Intervention
DRUG: Papaverine|DRUG: Heparin|DRUG: Rescue papaverine, as needed
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Prevention
Gender
All
Age
Child
Enrollment
100
Outcome Measure
Number of Participants With Optimal Arterial Waveform, Optimal waveform was defined as easy aspiration of a blood sample (negative aspiration is easy and draws back freely without cavitation, and takes no more than 30 seconds to draw 1 mL), absence of color change at the catheter insertion site, and presence of a dicrotic notch in the arterial pressure waveform (a distinct dicrotic notch implies system has good resolution at higher frequencies and is not overdamped)., 5 minutes after first dose
Sponsor Collaborator
The University of Texas Health Science Center, Houston
Funded By
OTHER
Location
UT Health, Houston, Texas, 77030, United States
Other Id
HSC-MS-19-0059
Start Date
2019-04-01
Primary Completion Date
2020-10-10
Completion Date
2020-10-10
First Posted
2019-03-29
Results First Posted
2022-10-27
Last Update Posted
2022-10-27
Study Document
Study Protocol, https://cdn.clinicaltrials.gov/large-docs/04/NCT03894904/Prot_001.pdf
Study Url
https://clinicaltrials.gov/study/NCT03894904
Title Cn
Title En
Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients
Bilingual Status
semi_complete