NCT03894904

Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pediatrics
• Anesthesia
• Vasospasm

Interventions

Type	Name	Description
DRUG	Papaverine	0.12 mg/mL papaverine administered as soon as the arterial catheter is placed and secured, and 0.12 mg/mL papaverine administered one hour after initial dose
DRUG	Heparin	2 units/mL heparin administered as soon as the arterial catheter is placed and secured, and 2 units/mL heparin administered one hour after initial dose
DRUG	Rescue papaverine, as needed	If the arterial catheter spasm/patency or waveform does not improve 10 minutes after the second papaverine plus heparin or heparin only dose, then the anesthesiology care team will consider treating clinically with 0.3 mg of papaverine.

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-10-10
• Completion: 2020-10-10
• First posted: 2019-03-29
• Last updated: 2022-10-27
• Results posted: 2022-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study