At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Papaverine, Heparin, and 1 other intervention for Pediatrics and 2 related conditions. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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
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
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.