Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT06067958
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012178', 'term': 'Retinopathy of Prematurity'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The units pharmacologist will be responsible for patient assignment and preparation of the medication / placebo syringes but will remain blinded to the other aspects of the trial. The patient's nurse, attending physician, ophthalmologist, investigator and outcome assessor will remain blinded to the patient allocation"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be a crossover, prospective randomized controlled trial. Block randomization will be performed before the first eye examination. Every participant will undergo two eye examinations - one following exposure to dexmedetomidine and one following placebo.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-10-03', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Premature Infant Pain Profile: Revised, at peak', 'timeFrame': 'PIPP-R score will be assessed 60 seconds after the insertion of the retractor', 'description': 'The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants \\<28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort.\n\nEvery participant will be assessed using video recordings which will start 5 minutes before the administration of oral sucrose 24% and will continue until 5 minutes after the removal of the eyelid retractor.\n\nThe primary outcome will be the PIPP-R score one minute after the insertion of the retractor.'}], 'secondaryOutcomes': [{'measure': 'The Premature Infant Pain Profile: Revised, 5 minutes', 'timeFrame': '5 minutes after the insertion of the retractor', 'description': 'The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants \\<28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort.\n\nFor this secondary outcome, PIPP-R score 5 minutes after the insertion of the retractor will be assessed.'}, {'measure': 'The Premature Infant Pain Profile: Revised, at completion', 'timeFrame': '2 minutes after the removal the retractors', 'description': 'The Premature Infant Pain Profile: Revised (PIPP-R) is a scoring system for pain and discomfort in preterm infants. The maximum attainable PIPP-R score is 21 for preterm infants \\<28 weeks GA and 18 for full-term infants. The higher the score, the greater the discomfort.\n\nFor this secondary outcome, PIPP-R score 2 minutes after the after the removal the retractors will be assessed.'}, {'measure': 'Apnea', 'timeFrame': 'From time 0 until 5 hours after the examination', 'description': 'Number of apneas or desaturations \\< 90%'}, {'measure': 'Bradycardia', 'timeFrame': 'From time 0 until 5 hours after the examination', 'description': 'Number of bradycardias, defined as a drop of 20% from baseline heart rate'}, {'measure': 'Heart rate', 'timeFrame': 'Assessed every hour from time 0 until 5 hours after the examination', 'description': 'The average heart rate of the infant'}, {'measure': 'Duration of examination', 'timeFrame': 'Up to 30 minutes', 'description': 'The time between the insertion and the removal of the retractor'}, {'measure': 'Percent of crying time', 'timeFrame': 'The duration of the video recording (up to 1 hour)', 'description': 'The percent of time in which the participant cried during the video recording'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retinopathy of Prematurity', 'Dexmedetomidine', 'Pain', 'Analgesia', 'Premature Infant Pain Profile - Revised'], 'conditions': ['Retinopathy of Prematurity', 'Dexmedetomidine']}, 'referencesModule': {'references': [{'pmid': '33674712', 'type': 'BACKGROUND', 'citation': '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': '34247850', 'type': 'BACKGROUND', 'citation': '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. International Classification of Retinopathy of Prematurity, Third Edition. Ophthalmology. 2021 Oct;128(10):e51-e68. doi: 10.1016/j.ophtha.2021.05.031. Epub 2021 Jul 8.'}, {'pmid': '31989459', 'type': 'BACKGROUND', 'citation': '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': '22123352', 'type': 'BACKGROUND', 'citation': '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': '25613847', 'type': 'BACKGROUND', 'citation': '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': '24866853', 'type': 'BACKGROUND', 'citation': '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': '30987942', 'type': 'BACKGROUND', 'citation': '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': '25376189', 'type': 'BACKGROUND', 'citation': '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': '15797982', 'type': 'BACKGROUND', 'citation': 'Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Ann Pharmacother. 2005 May;39(5):829-33. doi: 10.1345/aph.1E476. Epub 2005 Mar 29.'}, {'pmid': '29858451', 'type': 'BACKGROUND', 'citation': 'Disher T, Cameron C, Mitra S, Cathcart K, Campbell-Yeo M. Pain-Relieving Interventions for Retinopathy of Prematurity: A Meta-analysis. Pediatrics. 2018 Jul;142(1):e20180401. doi: 10.1542/peds.2018-0401. Epub 2018 Jun 1.'}, {'pmid': '21901708', 'type': 'BACKGROUND', 'citation': 'Dempsey E, McCreery K. Local anaesthetic eye drops for prevention of pain in preterm infants undergoing screening for retinopathy of prematurity. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD007645. doi: 10.1002/14651858.CD007645.pub2.'}, {'pmid': '30509742', 'type': 'BACKGROUND', 'citation': 'Campbell-Yeo M, Benoit B. Use of morphine before retinopathy of prematurity examinations. Lancet. 2018 Dec 15;392(10164):2521-2523. doi: 10.1016/S0140-6736(18)32324-9. Epub 2018 Nov 30. No abstract available.'}, {'pmid': '36276254', 'type': 'BACKGROUND', 'citation': 'Alselaimy R, Al Tawil L, Abouammoh MA. Anesthesia in retinopathy of prematurity. Saudi J Ophthalmol. 2022 Oct 14;36(3):251-259. doi: 10.4103/sjopt.sjopt_229_21. eCollection 2022 Jul-Sep.'}, {'pmid': '30509743', 'type': 'BACKGROUND', 'citation': 'Hartley C, Moultrie F, Hoskin A, Green G, Monk V, Bell JL, King AR, Buckle M, van der Vaart M, Gursul D, Goksan S, Juszczak E, Norman JE, Rogers R, Patel C, Adams E, Slater R. Analgesic efficacy and safety of morphine in the Procedural Pain in Premature Infants (Poppi) study: randomised placebo-controlled trial. Lancet. 2018 Dec 15;392(10164):2595-2605. doi: 10.1016/S0140-6736(18)31813-0. Epub 2018 Nov 30.'}, {'pmid': '32054982', 'type': 'BACKGROUND', 'citation': 'Sindhur M, Balasubramanian H, Srinivasan L, Kabra NS, Agashe P, Doshi A. Intranasal fentanyl for pain management during screening for retinopathy of prematurity in preterm infants: a randomized controlled trial. J Perinatol. 2020 Jun;40(6):881-887. doi: 10.1038/s41372-020-0608-2. Epub 2020 Feb 13.'}, {'pmid': '35197548', 'type': 'BACKGROUND', 'citation': 'McDonald D, Palsgraf H, Shah P. Dexmedetomidine - An emerging option for sedation in neonatal patients. J Perinatol. 2022 Jul;42(7):845-855. doi: 10.1038/s41372-022-01351-3. Epub 2022 Feb 23.'}, {'pmid': '23258968', 'type': 'BACKGROUND', 'citation': "O'Mara K, Gal P, Wimmer J, Ransom JL, Carlos RQ, Dimaguila MA, Davanzo CC, Smith M. Dexmedetomidine versus standard therapy with fentanyl for sedation in mechanically ventilated premature neonates. J Pediatr Pharmacol Ther. 2012 Jul;17(3):252-62. doi: 10.5863/1551-6776-17.3.252."}, {'pmid': '11753013', 'type': 'BACKGROUND', 'citation': 'Laudenbach V, Mantz J, Lagercrantz H, Desmonts JM, Evrard P, Gressens P. Effects of alpha(2)-adrenoceptor agonists on perinatal excitotoxic brain injury: comparison of clonidine and dexmedetomidine. Anesthesiology. 2002 Jan;96(1):134-41. doi: 10.1097/00000542-200201000-00026.'}, {'pmid': '31246159', 'type': 'BACKGROUND', 'citation': 'Lewis J, Bailey CR. Intranasal dexmedetomidine for sedation in children; a review. J Perioper Pract. 2020 Jun;30(6):170-175. doi: 10.1177/1750458919854885. Epub 2019 Jun 27.'}, {'pmid': '30144232', 'type': 'BACKGROUND', 'citation': 'Bua J, Massaro M, Cossovel F, Monasta L, Brovedani P, Cozzi G, Barbi E, Demarini S, Travan L. Intranasal dexmedetomidine, as midazolam-sparing drug, for MRI in preterm neonates. Paediatr Anaesth. 2018 Aug;28(8):747-748. doi: 10.1111/pan.13454. No abstract available.'}, {'pmid': '20645951', 'type': 'BACKGROUND', 'citation': 'Yuen VM, Hui TW, Irwin MG, Yao TJ, Wong GL, Yuen MK. Optimal timing for the administration of intranasal dexmedetomidine for premedication in children. Anaesthesia. 2010 Sep;65(9):922-9. doi: 10.1111/j.1365-2044.2010.06453.x.'}, {'pmid': '24503979', 'type': 'BACKGROUND', 'citation': 'Stevens BJ, Gibbins S, Yamada J, Dionne K, Lee G, Johnston C, Taddio A. The premature infant pain profile-revised (PIPP-R): initial validation and feasibility. Clin J Pain. 2014 Mar;30(3):238-43. doi: 10.1097/AJP.0b013e3182906aed.'}, {'pmid': '28066825', 'type': 'BACKGROUND', 'citation': 'Slater R, Hartley C, Moultrie F, Adams E, Juszczak E, Rogers R, Norman JE, Patel C, Stanbury K, Hoskin A, Green G; Poppi Trial Team. A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol. Wellcome Open Res. 2016 Nov 15;1:7. doi: 10.12688/wellcomeopenres.10005.2.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPurpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations.\n\nThe main questions it aims to answer are:\n\n* Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%).\n* Does dexmedetomidine cause more adverse effects than placebo.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age \\< 31 weeks post-menstrual age, or birth weight \\< 1500 grams\n* Informed consent signed by one of the parents\n\nExclusion Criteria:\n\n* Invasive ventilation at the time of the eye assessment\n* Multiple congenital anomalies\n* Chromosomal / genetic anomalies\n* Infant received a sedative drug in last 5 days\n* Eye examination for reasons other than retinopathy of prematurity screening\n* Attending physician deemed the patient not stable enough'}, 'identificationModule': {'nctId': 'NCT06067958', 'briefTitle': 'Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity: a Crossover Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '0096-23-ASF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Intranasal Dexmedetomidine 2 microgram/kilogram, 30 minutes before eye examination', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "Saline 0.9%, volume will change to match that of dexmedetomidine based on participants' weight. 30 minutes before eye examination", 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Saline', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7033001', 'city': 'Be’er Ya‘aqov', 'state': 'Center', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sagee Nissimov, MD', 'role': 'CONTACT', 'email': 'sageen@shamir.gov.il', 'phone': '97289779080'}, {'name': 'Sagee Nissimov, MD', 'role': 'CONTACT'}, {'name': 'Sigal Zmujack-Yehiam, MD', 'role': 'CONTACT'}, {'name': 'Iris Morag, MD', 'role': 'CONTACT'}], 'facility': 'Assaf-Harofeh Medical Center', 'geoPoint': {'lat': 31.93864, 'lon': 34.83749}}], 'centralContacts': [{'name': 'Sagee Nissimov, MD', 'role': 'CONTACT', 'email': 'sageen@shamir.gov.il', 'phone': '97289779080'}, {'name': 'Iris Morag, MD', 'role': 'CONTACT', 'email': 'IRISMO@shamir.gov.il', 'phone': '97289778286'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sagee Nissimov', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}