Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Официальное название

Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial

Обзор

Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain. Purpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations. The main questions it aims to answer are: * Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%). * Does dexmedetomidine cause more adverse effects than placebo. In this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.

Вмешательства

• Препарат Dexmedetomidine
  Intranasal administration of dexmedetomidine will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.
• Препарат Saline
  Intranasal administration of saline 0.9% will be done using MAD Nasal atomization device (Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville, NC 27560, USA). Administration will be given to both nares at a similar volume.

Первичные конечные точки

• The Premature Infant Pain Profile: Revised, at peak [Срок оценки: PIPP-R score will be assessed 60 seconds after the insertion of the retractor]

Вторичные конечные точки (7)

• The Premature Infant Pain Profile: Revised, 5 minutes [Срок оценки: 5 minutes after the insertion of the retractor]
• The Premature Infant Pain Profile: Revised, at completion [Срок оценки: 2 minutes after the removal the retractors]
• Apnea [Срок оценки: From time 0 until 5 hours after the examination]
• Bradycardia [Срок оценки: From time 0 until 5 hours after the examination]
• Heart rate [Срок оценки: Assessed every hour from time 0 until 5 hours after the examination]
• Duration of examination [Срок оценки: Up to 30 minutes]
• Percent of crying time [Срок оценки: The duration of the video recording (up to 1 hour)]

Критерии участия

Критерии включения

• Gestational age < 31 weeks post-menstrual age, or birth weight < 1500 grams
• Informed consent signed by one of the parents

Критерии исключения

• Invasive ventilation at the time of the eye assessment
• Multiple congenital anomalies
• Chromosomal / genetic anomalies
• Infant received a sedative drug in last 5 days
• Eye examination for reasons other than retinopathy of prematurity screening
• Attending physician deemed the patient not stable enough

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Assaf-Harofeh Medical Center — Be’er Ya‘aqov

Публикации

• Wood EH, Chang EY, Beck K, Hadfield BR, Quinn AR, Harper CA 3rd. 80 Years of vision: preventing blindness from retinopathy of prematurity. J Perinatol. 2021 Jun;41(6):1216-1224. doi: 10.1038/s41372-021-01015-8. Epub 2021 Mar 5. PMID 33674712
• Chiang MF, Quinn GE, Fielder AR, Ostmo SR, Paul Chan RV, Berrocal A, Binenbaum G, Blair M, Peter Campbell J, Capone A Jr, Chen Y, Dai S, Ells A, Fleck BW, Good WV, Elizabeth Hartnett M, Holmstrom G, Kusaka S, Kychenthal A, Lepore D, Lorenz B, Martinez-Castellanos MA, Ozdek S, Ademola-Popoola D, Reynolds JD, Shah PK, Shapiro M, Stahl A, Toth C, Vinekar A, Visser L, Wallace DK, Wu WC, Zhao P, Zin A. PMID 34247850
• Nayak R, Nagaraj KN, Gururaj G. Prevention of Pain During Screening for Retinopathy of Prematurity: A Randomized Control Trial Comparing Breast Milk, 10% Dextrose and Sterile Water. Indian J Pediatr. 2020 May;87(5):353-358. doi: 10.1007/s12098-020-03182-6. Epub 2020 Jan 27. PMID 31989459
• 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. PMID 22123352
• Padhi TR, Sareen D, Pradhan L, Jalali S, Sutar S, Das T, Modi RR, Behera UC. Evaluation of retinopathy of prematurity screening in reverse Kangaroo Mother Care: a pilot study. Eye (Lond). 2015 Apr;29(4):505-8. doi: 10.1038/eye.2014.340. Epub 2015 Jan 23. PMID 25613847
• Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114. PMID 24866853
• Walker SM. Long-term effects of neonatal pain. Semin Fetal Neonatal Med. 2019 Aug;24(4):101005. doi: 10.1016/j.siny.2019.04.005. Epub 2019 Apr 5. PMID 30987942
• Nesargi SV, Nithyanandam S, Rao S, Nimbalkar S, Bhat S. Topical anesthesia or oral dextrose for the relief of pain in screening for retinopathy of prematurity: a randomized controlled double-blinded trial. J Trop Pediatr. 2015 Feb;61(1):20-4. doi: 10.1093/tropej/fmu058. Epub 2014 Nov 5. PMID 25376189

Идентификаторы

NCT: NCT06067958 · 0096-23-ASF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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