Clinical trial NCT03894904: Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients
Official title: Double-Blind, Randomized, Controlled Trial, Small Volume Bolus of Papaverine Versus Heparin to Maintain Patency of Peripheral Arterial Catheters in Pediatric Patients Undergoing Surgical Procedures: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatrics
Anesthesia
Vasospasm
Keywords: Heparin
Papaverine
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 100
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare intraoperative papaverine plus heparin to heparin alone for prevention of arterial spasm and maintenance of patency of peripheral arterial catheters during surgery in pediatric patients. The hypothesis is that periodic, intraoperative small-volume boluses of diluted papaverine plus heparin in peripheral arterial catheters of pediatric patients will prevent arterial spasm and help maintain patency of arterial catheters during general anesthesia.

Detailed description: Peripheral arterial catheters measure blood pressure with every heartbeat and provide valuable information regarding the status of the heart and the overall well being. It is of utmost importance to maintain the utility and patency of these catheters throughout the procedure. As standard procedure, heparin, a blood thinner, is used routinely during the surgical procedure to keep these catheters from clotting, and papaverine, an arterial relaxation agent, is used after surgery to maintain patency of these catheters.

In this study, participants will be randomized to receive two boluses of papaverine with heparin during the procedure (experimental arm) or heparin alone during the procedure (control arm) \[in both arms, the first bolus will be administered as soon as the arterial catheter is placed and secured and again one hour after initial bolus\]. If the arterial catheter spasm/patency or waveform does not improve 10 minutes after the second bolus, then the anesthesiology care team will consider treating clinically with 0.3 mg of papaverine.

Eligibility criteria: Inclusion Criteria:

- All patients age 0-17 years who would require elective placements of arterial catheters based on patients clinical complexity (ex. congenital heart disease) or based on the type of surgery (ex. open heart surgery).

Exclusion Criteria:

* Patients with a history of significant liver dysfunction.
* Patients undergoing liver transplants.
* Patients with Grade 2 or more of intraventricular hemorrhage.
* All preterm patients with a gestational age less than 37 weeks at the time of surgery.

Primary outcomes:
measure: Number of Participants With Optimal Arterial Waveform
timeFrame: 5 minutes after first dose
Secondary outcomes:
measure: Number of Participants With Optimal Arterial Waveform
timeFrame: 60 minutes after first dose
measure: Number of Participants With Suboptimal Waveforms Who Received Rescue Papaverine and for Whom Papaverine Rescued Suboptimal Waveforms
timeFrame: 5 minutes after injection of rescue papaverine (about 70 minutes after first study drug dose and about 10 minutes after second study drug dose)
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT Health
state: Texas
Study officials:
affiliation: UTHealth
name: Nischal K Gautam, MD
role: STUDY_DIRECTOR
References: