Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT03894904
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 18.3
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

Periodic small volume boluses of diluted papaverine in peripheral arterial catheters of pediatric patients will prevent arterial spasm and help maintain patency of arterial catheters during general anesthesia.

Condition or Disease	Intervention/Treatment	Phase
Pediatrics; Anesthesia; Vasospasm	Drug: Papaverine; Drug: Heparin	Phase 4

Detailed Description

The purpose of this study is to assess the best possible technique to prevent arterial spasm and maintain patency of peripheral arterial catheters during surgery in pediatric patients. 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. Papaverine, an arterial relaxation agent, is used after surgery to maintain patency of these catheters. In this study, small volumes of papaverine with heparin will be introduced during the procedure (1 mL of a 0.12 mg/mL papaverine, Heparin 2 units/mL premixed syringe made by the pharmacy) (treatment group) or after the procedure (control group).

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Apr 1, 2019
• Actual Primary Completion Date: Oct 10, 2020
• Actual Study Completion Date: Oct 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Premixed Papaverine 2mL of the 50mL premixed syringe of papaverine as dispensed from pharmacy ( NaCl 0.9% inj 48.8 mL + papaverine 6mg+ heparin 100 units).	Drug: Papaverine; 1mL volume bolus will be given from the "research syringe" as soon as the arterial catheter is placed. Another subsequent 1mL bolus will be given one hour after the initial bolus if needed.
Active Comparator: Heparin 2 ml of the 10 mL of 2 units/mL of heparin from the pressurized fast flush bag from the operating room.	Drug: Heparin; 1mL volume bolus will be given from the "research syringe" as soon as the arterial catheter is placed. Another subsequent 1mL bolus will be given one hour after the initial bolus if needed.

Outcome Measures

Primary Outcome Measures

1. Color changes at catheter site [Indicators of arterial waveform patency performed from baseline and then every 1 hour intraoperatively]

   Presence or absence of local axon reflex with fluid flushes after placement) when the arterial line is accessible.

2. Presence/ absence of a dicrotic notch [Indicators of arterial waveform patency performed from baseline and then every 1 hour intraoperatively]

   A distinct dicrotic notch implies system has good resolution at higher frequencies and is not overdamped.

3. Ability to draw lab sample [Indicators of arterial waveform patency performed from baseline and then every 1 hour intraoperatively]

   I. Negative aspiration is easy and draws back freely without cavitation using a 3 mL BD syringe. II. Negative aspiration is difficult (cavitation during negative aspiration, takes more than 30 seconds to draw 1 mL) using a 3 mL BD syringe.

4. Square wave test [Indicators of arterial waveform patency performed from baseline and then every 1 hour intraoperatively]

   A fast flush system will be used. Pressure bag will be set to 300 mmHg and the resultant waveform will be recorded on paper.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Health	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston

Investigators

• Study Director: Nischal K Gautam, MD, UTHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nischal Krishamurthy Gautam, Associate Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03894904
• Other Study ID Numbers: HSC-MS-19-0059
• First Posted: Mar 29, 2019
• Last Update Posted: Apr 13, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Nischal Krishamurthy Gautam, Associate Professor, The University of Texas Health Science Center, Houston: Heparin; Papaverine
• Additional relevant MeSH terms: Heparin; Papaverine

Study Results

No Results Posted as of Apr 13, 2021