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Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT03894904
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Nischal Krishamurthy Gautam, The University of Texas Health Science Center, Houston

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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.




Primary Outcome Measures :
  1. Color changes at catheter site [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894904


Contacts
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Contact: Cassandra B Howell, MD 713-500-6200 cassandra.b.howell@uth.tmc.edu
Contact: James A Pierre, Jr. 713-500-6301 james.a.pierre@uth.tmc.edu

Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Study Director: Nischal K Gautam, MD UTHealth

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Responsible Party: Nischal Krishamurthy Gautam, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03894904     History of Changes
Other Study ID Numbers: HSC-MS-19-0059
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, The University of Texas Health Science Center, Houston:
Heparin
Papaverine

Additional relevant MeSH terms:
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Heparin
Calcium heparin
Papaverine
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Urological Agents