Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients

Phase 4

Completed

Conditions: Pediatrics
Anesthesia
Vasospasm

Interventions: Drug: Papaverine
Drug: Rescue papaverine, as needed
Drug: Heparin

Registration Number: NCT03894904

Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin during procedure, with rescue papaverine as needed	Rescue papaverine, as needed	1 mL bolus of heparin (2 units/mL) in saline (NaCl 0.9%) will be administered as soon as the arterial catheter is placed and secured, and a 1 mL bolus of heparin (2 units/mL) in saline (NaCl 0.9%) will be administered 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.
Papaverine plus heparin during procedure, with rescue papaverine as needed	Rescue papaverine, as needed	1 mL bolus of papaverine (0.12 mg/mL) plus heparin (2 units/mL) in saline (NaCl 0.9%) will be administered as soon as the arterial catheter is placed and secured, and a 1 mL bolus of papaverine (0.12 mg/mL) plus heparin (2 units/mL) in saline (NaCl 0.9%) will be administered 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.
Papaverine plus heparin during procedure, with rescue papaverine as needed	Papaverine	1 mL bolus of papaverine (0.12 mg/mL) plus heparin (2 units/mL) in saline (NaCl 0.9%) will be administered as soon as the arterial catheter is placed and secured, and a 1 mL bolus of papaverine (0.12 mg/mL) plus heparin (2 units/mL) in saline (NaCl 0.9%) will be administered 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.
Papaverine plus heparin during procedure, with rescue papaverine as needed	Heparin	1 mL bolus of papaverine (0.12 mg/mL) plus heparin (2 units/mL) in saline (NaCl 0.9%) will be administered as soon as the arterial catheter is placed and secured, and a 1 mL bolus of papaverine (0.12 mg/mL) plus heparin (2 units/mL) in saline (NaCl 0.9%) will be administered 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.
Heparin during procedure, with rescue papaverine as needed	Heparin	1 mL bolus of heparin (2 units/mL) in saline (NaCl 0.9%) will be administered as soon as the arterial catheter is placed and secured, and a 1 mL bolus of heparin (2 units/mL) in saline (NaCl 0.9%) will be administered 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Optimal Arterial Waveform	5 minutes after first dose	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Optimal Arterial Waveform	60 minutes after first dose	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).
Number of Participants With Suboptimal Waveforms Who Received Rescue Papaverine and for Whom Papaverine Rescued Suboptimal Waveforms	5 minutes after injection of rescue papaverine (about 70 minutes after first study drug dose and about 10 minutes after second study drug dose)	These data were collected only from participants who received rescue papaverine. 7 in the Papaverine plus Heparin arm received rescue papaverine. 17 in the Heparin arm received rescue papaverine.