Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal CPAP Continuous Positive Airway Pressure
NCT ID: NCT02268968
Last Updated: 2015-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
60 participants
INTERVENTIONAL
2013-10-31
2014-12-31
Brief Summary
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Detailed Description
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This study proposes a randomized controlled trial to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Lidocaine
Intervention: Topical lidocaine gel 2% (0.3 ml/kg) will be applied once only to the nostrils and nasal CPAP prong 5 minutes prior to the application of nasal CPAP
Lidocaine 2% Gel
Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP
Control
No topical lidocaine will be used prior to application of nasal CPAP
No interventions assigned to this group
Interventions
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Lidocaine 2% Gel
Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to NICU, Mansoura University Children's Hospital
* Respiratory distress requiring use of nasal CPAP
* Informed consent obtained
Exclusion Criteria
* Use of sedation, analgesia in the preceding 72 hours
* Those who undergo any surgical intervention
* Those who undergo any painful procedures as venipuncture, intubation, suctioning, blood sampling, heel-prick, catheterization 30 minutes before assessment
* Those with signs of nasal injuries at the time of application of nCPAP
* Necrotizing enterocolitis
28 Days
ALL
No
Sponsors
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Mansoura University Children Hospital
OTHER
Responsible Party
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Hesham Abdel-Hady
Professor of Pediatrics
Principal Investigators
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Hesham E Abdel-Hady, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mansoura University Children Hospital
Locations
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Neonatal Intensive Care Unit, Mansoura University Children Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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References
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Britto CD, Rao Pn S, Nesargi S, Nair S, Rao S, Thilagavathy T, Ramesh A, Bhat S. PAIN--perception and assessment of painful procedures in the NICU. J Trop Pediatr. 2014 Dec;60(6):422-7. doi: 10.1093/tropej/fmu039. Epub 2014 Jul 21.
Prevention and management of pain and stress in the neonate. American Academy of Pediatrics. Committee on Fetus and Newborn. Committee on Drugs. Section on Anesthesiology. Section on Surgery. Canadian Paediatric Society. Fetus and Newborn Committee. Pediatrics. 2000 Feb;105(2):454-61.
Bendixen D, Halvorsen AC, Hjelt K, Flachs H. Lignocaine gel used for lubrication of intranasal and endotracheal tubes in premature neonates. Acta Paediatr. 1994 May;83(5):493-7. doi: 10.1111/j.1651-2227.1994.tb13065.x.
Lillieborg S, Otterbom I, Ahlen K. Topical anaesthesia in neonates, infants and children. Br J Anaesth. 2004 Mar;92(3):450; author reply 450-1. doi: 10.1093/bja/aeh522. No abstract available.
Other Identifiers
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MS 012
Identifier Type: -
Identifier Source: org_study_id
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