Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.

Summary

The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening. The main question it aims to answer is: • Does use of intranasal midazolam is a safe, quick, non-invasive medication, that reduces the pain, stress, discomfort, and other complications in patients undergoing ROP screening? Researchers will compare the intervention group with a comparison group of the patients who will receive routine comfort care.

Timeline

Start

2025-03-24

Primary completion

2025-06-01

Completion

2025-07-06

Publications

• Background Salaets T, Lacaze-Masmonteil T, Hokuto I, Gauldin C, Taha A, Smits A, Thewissen L, Van Horebeek I, Shoraisham A, Mohammad K, Suzuki M, Komachi S, Michels K, Turner MA, Allegaert K, Lewis T. Prospective assessment of inter-rater reliability of a neonatal adverse event severity scale. Front Pharmacol. 2023 Sep 7;14:1237982. doi: 10.3389/fphar.2023.1237982. eCollection 2023.
• Background Salaets T, Turner MA, Short M, Ward RM, Hokuto I, Ariagno RL, Klein A, Beauman S, Wade K, Thomson M, Roberts E, Harrison J, Quinn T, Baer G, Davis J, Allegaert K; International Neonatal Consortium. Development of a neonatal adverse event severity scale through a Delphi consensus approach. Arch Dis Child. 2019 Dec;104(12):1167-1173. doi: 10.1136/archdischild-2019-317399. Epub 2019 Sep 19.
• Background Morgan ME, Kukora S, Nemshak M, Shuman CJ. Neonatal Pain, Agitation, and Sedation Scale's use, reliability, and validity: a systematic review. J Perinatol. 2020 Dec;40(12):1753-1763. doi: 10.1038/s41372-020-00840-7. Epub 2020 Oct 2.
• Background Vinall J, Miller SP, Chau V, Brummelte S, Synnes AR, Grunau RE. Neonatal pain in relation to postnatal growth in infants born very preterm. Pain. 2012 Jul;153(7):1374-1381. doi: 10.1016/j.pain.2012.02.007.
• Background COMMITTEE ON FETUS AND NEWBORN and SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE. Prevention and Management of Procedural Pain in the Neonate: An Update. Pediatrics. 2016 Feb;137(2):e20154271. doi: 10.1542/peds.2015-4271. Epub 2016 Jan 25.
• Background Snyers D, Tribolet S, Rigo V. Intranasal Analgosedation for Infants in the Neonatal Intensive Care Unit: A Systematic Review. Neonatology. 2022;119(3):273-284. doi: 10.1159/000521949. Epub 2022 Mar 1.
• Background Pasero C. Pain assessment in infants and young children: Premature Infant Pain Profile. Am J Nurs. 2002 Sep;102(9):105-6. doi: 10.1097/00000446-200209000-00065. No abstract available.
• Background Francis K. What Is Best Practice for Providing Pain Relief During Retinopathy of Prematurity Eye Examinations? Adv Neonatal Care. 2016 Jun;16(3):220-8. doi: 10.1097/ANC.0000000000000267.
• Background Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the premature infant pain profile in the clinical setting. Clin J Pain. 1999 Dec;15(4):297-303. doi: 10.1097/00002508-199912000-00006.
• Background Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.
• Background Mitchell AJ, Green A, Jeffs DA, Roberson PK. Physiologic effects of retinopathy of prematurity screening examinations. Adv Neonatal Care. 2011 Aug;11(4):291-7. doi: 10.1097/ANC.0b013e318225a332.
• Background Moral-Pumarega MT, Caserio-Carbonero S, De-La-Cruz-Bertolo J, Tejada-Palacios P, Lora-Pablos D, Pallas-Alonso CR. Pain and stress assessment after retinopathy of prematurity screening examination: indirect ophthalmoscopy versus digital retinal imaging. BMC Pediatr. 2012 Aug 28;12:132. doi: 10.1186/1471-2431-12-132.
• Background Thirunavukarasu AJ, Hassan R, Savant SV, Hamilton DL. Analgesia for retinopathy of prematurity screening: A systematic review. Pain Pract. 2022 Sep;22(7):642-651. doi: 10.1111/papr.13138. Epub 2022 Jun 27.
• Background Slevin M, Murphy JF, Daly L, O'Keefe M. Retinopathy of prematurity screening, stress related responses, the role of nesting. Br J Ophthalmol. 1997 Sep;81(9):762-4. doi: 10.1136/bjo.81.9.762.

Drugs

Indications

No indication recorded.