Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients

NCT03894904 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-19-0059
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatrics; Anesthesia; Vasospasm

Keywords

Heparin; Papaverine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of Participants With Optimal Arterial Waveform

  60 minutes after first dose

• 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)

Study Arms (2)

Papaverine plus heparin during procedure, with rescue papaverine as needed

EXPERIMENTAL

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.

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

Heparin during procedure, with rescue papaverine as needed

ACTIVE COMPARATOR

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.

Drug: Heparin; Drug: Rescue papaverine, as needed

Interventions

Papaverine DRUG

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

Papaverine plus heparin during procedure, with rescue papaverine as needed

Heparin DRUG

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

Heparin during procedure, with rescue papaverine as needed; Papaverine plus heparin during procedure, with rescue papaverine as needed

Rescue papaverine, as needed DRUG

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.

Heparin during procedure, with rescue papaverine as needed; Papaverine plus heparin during procedure, with rescue papaverine as needed

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UT Health

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Papaverine; Heparin

Intervention Hierarchy (Ancestors)

Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Opiate Alkaloids; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Nischal K. Gautam, MD
• Organization: The University of Texas Health Science Center at Houston

Nischal.K.Gautam@uth.tmc.edu

(713) 500-6200

Study Officials

• Nischal K Gautam, MD

  UTHealth

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 29, 2019
• Study Start: April 1, 2019
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: October 27, 2022
• Results First Posted: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)