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Introduction <p>Venipuncture is a common and painful procedure in neonates. Sweet solutions (sucrose and glucose) are recommended and widely used as standard care for reducing neonatal procedural pain. Topical local anesthetics may also reduce procedural pain but generally require longer application times to achieve adequate analgesia. This study investigated the efficacy and safety of a novel topical lidocaine–nitroglycerin preparation as an adjunct to standard oral sweet solutions in neonates undergoing peripheral venous catheterization.</p> Methods <p>In this double-blind randomized clinical trial, 84 neonates (≥ 34 weeks gestation) undergoing peripheral venous catheterization were randomized to receive either topical lidocaine/nitroglycerin 2% or placebo ointment, applied 15&#xa0;min before the procedure. All neonates in both groups received 0.5 mL of 24% oral sucrose two minutes before venipuncture as standard care. Pain was assessed using the Premature Infant Pain Profile (PIPP) and Neonatal Facial Coding System (NFCS) scales using standardized procedures and video verification. The duration of crying, time to cry onset, number of venipuncture attempts, and adverse events were recorded.</p> Results <p>Neonates treated with lidocaine–nitroglycerin topical formulation plus standard oral sucrose had significantly lower PIPP scores [7.0 vs. 8.5, <i>P</i> = 0.038] and NFCS scores [5.0 vs. 7.0, <i>P</i> &lt; 0.001] compared with placebo ointment plus standard oral sucrose. Crying duration was significantly shorter [10&#xa0;s vs. 25&#xa0;s, <i>P</i> = 0.045], and fewer neonates required repeated venipuncture (6 vs. 14, <i>P</i> = 0.041). No adverse reactions or clinical signs of methemoglobinemia were observed.</p> Conclusion <p>Topical lidocaine/nitroglycerin 2% provided rapid analgesia and reduced repeated venipuncture attempts in neonates, offering a practical strategy for pain management in the neonatal intensive care unit (NICU). Further large multicenter trials are warranted to confirm efficacy and long-term safety.</p> Trial Registration <p>The trial was registered as IRCT20190810044500N19 (22/08/2021) <a href="https://irct.behdasht.gov.ir/trial/47524">https://irct.behdasht.gov.ir/trial/47524</a>.</p>

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A novel topical nitroglycerin-lidocaine combination for procedural pain management and rapid cannulation in neonates: results from a randomized controlled clinical trial

  • 期刊论文

  • 发表日期：

    2026年7月25日

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  • Fatemeh Saghafi,
  • Farhad Mohammadi,
  • Mohadesah Esmaeili,
  • Mahmoud Nouri Shadkam,
  • Adeleh Sahebnasagh

摘要

Introduction

Venipuncture is a common and painful procedure in neonates. Sweet solutions (sucrose and glucose) are recommended and widely used as standard care for reducing neonatal procedural pain. Topical local anesthetics may also reduce procedural pain but generally require longer application times to achieve adequate analgesia. This study investigated the efficacy and safety of a novel topical lidocaine–nitroglycerin preparation as an adjunct to standard oral sweet solutions in neonates undergoing peripheral venous catheterization.

Methods

In this double-blind randomized clinical trial, 84 neonates (≥ 34 weeks gestation) undergoing peripheral venous catheterization were randomized to receive either topical lidocaine/nitroglycerin 2% or placebo ointment, applied 15 min before the procedure. All neonates in both groups received 0.5 mL of 24% oral sucrose two minutes before venipuncture as standard care. Pain was assessed using the Premature Infant Pain Profile (PIPP) and Neonatal Facial Coding System (NFCS) scales using standardized procedures and video verification. The duration of crying, time to cry onset, number of venipuncture attempts, and adverse events were recorded.

Results

Neonates treated with lidocaine–nitroglycerin topical formulation plus standard oral sucrose had significantly lower PIPP scores [7.0 vs. 8.5, P = 0.038] and NFCS scores [5.0 vs. 7.0, P < 0.001] compared with placebo ointment plus standard oral sucrose. Crying duration was significantly shorter [10 s vs. 25 s, P = 0.045], and fewer neonates required repeated venipuncture (6 vs. 14, P = 0.041). No adverse reactions or clinical signs of methemoglobinemia were observed.

Conclusion

Topical lidocaine/nitroglycerin 2% provided rapid analgesia and reduced repeated venipuncture attempts in neonates, offering a practical strategy for pain management in the neonatal intensive care unit (NICU). Further large multicenter trials are warranted to confirm efficacy and long-term safety.

Trial Registration

The trial was registered as IRCT20190810044500N19 (22/08/2021) https://irct.behdasht.gov.ir/trial/47524.