Phase 4
N=96
Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients
Pediatrics · Anesthesia · Vasospasm
Bottom Line
View on ClinicalTrials.gov: NCT03894904 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Number of Participants With Optimal Arterial Waveform — 27; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Papaverine (Drug); Heparin (Drug); Rescue papaverine, as needed (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Optimal Arterial Waveform |
30; 28 | — |
| SECONDARY Number of Participants With Optimal Arterial Waveform |
30; 28 | — |
| SECONDARY Number of Participants With Suboptimal Waveforms Who Received Rescue Papaverine and for Whom Papaverine Rescued Suboptimal Waveforms |
3; 13 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03894904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.