Clinical trial NCT02268968: Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal CPAP Continuous Positive Airway Pressure
Official title: Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal Contiuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Other Preterm Infants
Keywords: Topical Lidocaine
Nasal CPAP
Pain
Preterm Infants
Salivary cortisol
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 60
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main purpose of this study is to evaluate the relative efficacy of topical lidocaine on reducing pain associated with the application of nasal CPAP in preterm infants

Detailed description: Preterm infants admitted to NICUs are exposed to a range of painful procedures. The exposure to pain during this critical of brain development may have adverse consequences. Application of nasal CPAP is one of the painful procedures. A consensus statement on neonatal pain made recommendations for analgesia for neonatal procedures. Topical lidocaine is frequently used as a topical anesthetic during venipuncture, heel lancing, circumcision, endotracheal intubations, nasogastric tube insertion, endoscopy and bronchoscopy. However, the use of topical lidocaine for its analgesic effect on application of nasal CPAP has not been evaluated.

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.

Eligibility criteria: Inclusion Criteria:

* Preterm infants \< 37 weeks gestation
* Admitted to NICU, Mansoura University Children's Hospital
* Respiratory distress requiring use of nasal CPAP
* Informed consent obtained

Exclusion Criteria:

* Serious, life-threatening malformations
* 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

Primary outcomes:
measure: The Premature Infant Pain (PIPP) Scale
timeFrame: Immediately after application of nasal CPAP (approx 5 min)
Secondary outcomes:
measure: Salivary cortisol
timeFrame: 30 minute after application of nasal CPAP
measure: Duration of first cry
timeFrame: Immediately after application of nasal CPAP (approx 5 min)
measure: Possible adverse effects to lidocaine
timeFrame: Within 72 hours of application of topical lidocaine gel
measure: Nasal trauma
timeFrame: 24 hours after application of nasal CPAP
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Neonatal Intensive Care Unit, Mansoura University Children Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University Children Hospital
name: Hesham E Abdel-Hady, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.