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Subcutaneous Nitroglycerin for Pediatric Radial Artery Cannulation

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Arterial Line

Treatments

Drug: Nitroglycerin
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03849183
H-1810-077-979

Details and patient eligibility

About

The primary objective of the study is to evaluate the vasodilative effect of subcutaneous nitroglycerin during ultrasound-guided radial artery cannulation in pediatric patients. The hypothesis of this study is that the subcutaneous nitroglycerin will increase the radial artery size and improve the first-attempt success rate of radial artery cannulation. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of subcutaneous nitroglycerin and saline on radial artery cannulation in pediatric patients undergoing general anesthesia. Prior to the procedure, each patient will be randomized into either the control arm, saline, or study arm, nitroglycerin.

Enrollment

116 patients

Sex

All

Ages

Under 2 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • General anesthesia
  • Arterial cannulation for hemodynamic monitoring, multiple blood sample

Exclusion criteria

  • Hypersensitivity or contraindication to nitroglycerine
  • Unstable vital sign, significant arrhythmia or hypotension, Shock
  • High risk of peripheral ischemia
  • Skin disease, infection, hematoma, recent cannulation at radial artery.
  • Increased intracranial pressure, Intracranial hemorrhage
  • Glaucoma
  • Recent use of PDE5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

116 participants in 2 patient groups

Nitroglycerin
Experimental group
Description:
Nitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation.
Treatment:
Drug: Nitroglycerin
Control
Active Comparator group
Description:
Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation.
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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