Trial reportEuropean journal of clinical pharmacology2026
A novel topical nitroglycerin-lidocaine combination for procedural pain management and rapid cannulation in neonates: results from a randomized controlled clinical trial.
Trial report in European journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionVenipuncture 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.
methodsIn 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.
resultsNeonates 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.
conclusionTopical 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 registrationThe trial was registered as IRCT20190810044500N19 (22/08/2021) https://irct.behdasht.gov.ir/trial/47524 .
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