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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitroglycerin | Experimental | Nitroglycerin 5mcg/kg (0.5cc) is subcutaneously injected before radial artery cannulation. |
|
| Control | Active Comparator | Normal saline (0.5cc) is subcutaneously injected before radial artery cannulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin | Drug | Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| First attempt success rate | Success at the first skin puncture | During radial artery cannulation (up to 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Size of radial artery | Internal diameter of radial artery | Before and after subcutaneous injection of drugs (up to 1 hour) |
| depth of radial artery | depth of radial artery from the skin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jin-Tae Kim | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28923695 | Background | Chong AY, Lo T, George S, Ratib K, Mamas M, Nolan J. The effect of pre-procedure sublingual nitroglycerin on radial artery diameter and Allen's test outcome - Relevance to transradial catheterization. Cardiovasc Revasc Med. 2018 Mar;19(2):163-167. doi: 10.1016/j.carrev.2017.07.016. Epub 2017 Jul 29. | |
| 30002088 | Background |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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|
| Normal saline | Drug | Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients |
|
|
| Before and after subcutaneous injection of drugs (up to 1 hour) |
| Overall attempt | Number of attempt of radial artery cannulation | During radial artery cannulation (up to 1 hour) |
| Overall Procedure time | From ultrasound guidance, to Arterial waveform | During radial artery cannulation (up to 1 hour) |
| Overall success rate | Success within 4 skin puncture (2 skin puncture at each radial artery) | During radial artery cannulation (up to 1 hour) |
| Malfunction of radial artery catheter | Invasive blood pressure monitoring, Sampling | After radial artery cannulation assessed during anesthesia (up to 24 hour) |
| Complication rate | Hematoma, Distal ischemia, Spasm accessed by ultrasound | After radial artery cannulation assessed up to PACU, PICU stay (per 24hour, up to 48 hour) |
| Chen Y, Ke Z, Xiao J, Lin M, Huang X, Yan C, Ye S, Tan X. Subcutaneous Injection of Nitroglycerin at the Radial Artery Puncture Site Reduces the Risk of Early Radial Artery Occlusion After Transradial Coronary Catheterization: A Randomized, Placebo-Controlled Clinical Trial. Circ Cardiovasc Interv. 2018 Jul;11(7):e006571. doi: 10.1161/CIRCINTERVENTIONS.118.006571. |
| 28682811 | Background | Kim EH, Lee JH, Song IK, Kim JT, Lee WJ, Kim HS. Posterior Tibial Artery as an Alternative to the Radial Artery for Arterial Cannulation Site in Small Children: A Randomized Controlled Study. Anesthesiology. 2017 Sep;127(3):423-431. doi: 10.1097/ALN.0000000000001774. |
| 25634390 | Background | Ezhumalai B, Satheesh S, Jayaraman B. Effects of subcutaneously infiltrated nitroglycerin on diameter, palpability, ease-of-puncture and pre-cannulation spasm of radial artery during transradial coronary angiography. Indian Heart J. 2014 Nov-Dec;66(6):593-7. doi: 10.1016/j.ihj.2014.05.023. Epub 2014 Jun 7. |
| 23582415 | Background | Beyer AT, Ng R, Singh A, Zimmet J, Shunk K, Yeghiazarians Y, Ports TA, Boyle AJ. Topical nitroglycerin and lidocaine to dilate the radial artery prior to transradial cardiac catheterization: a randomized, placebo-controlled, double-blind clinical trial: the PRE-DILATE Study. Int J Cardiol. 2013 Oct 3;168(3):2575-8. doi: 10.1016/j.ijcard.2013.03.048. Epub 2013 Apr 10. |
| 22699036 | Background | Majure DT, Hallaux M, Yeghiazarians Y, Boyle AJ. Topical nitroglycerin and lidocaine locally vasodilate the radial artery without affecting systemic blood pressure: a dose-finding phase I study. J Crit Care. 2012 Oct;27(5):532.e9-13. doi: 10.1016/j.jcrc.2012.04.019. Epub 2012 Jun 12. |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |