Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal CPAP Continuous Positive Airway Pressure

NCT02268968 | Completed Phase 1 DMC

• 1 other identifier: MS 012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Other Preterm Infants

Keywords

Topical Lidocaine; Nasal CPAP; Pain; Preterm Infants; Salivary cortisol

Outcome Measures

Primary Outcomes (1)

• The Premature Infant Pain (PIPP) Scale

  PIPP comprises 3 behavioral variables (time of brow bulge, eye squeeze, and naso-labial furrow), 2 physiologic variables (changes in heart rate and SpO2), and 2 contextual variables (gestational age and behavioral state). Behavioral state ranges from "active/awake, eyes open, facial movements" to "quiet/sleep, eyes closed, no facial movements." Every variable will be scored on a scale from 0 to 3. A total score the sum of total of points indicating: lack of pain (0-6), mild -moderate pain (6-12) and severe pain (above 12). PIPP has documented reliability and validity and have been used previously in several studies in neonates. PIPP score measurement will be based on video recording the infant for 45 seconds. Three different DVDs will be compiled with the sets in random order. Three different nurses from NICU will be recruited to evaluate the segments. They will not be informed of the nature of the study. All 3 nurses are trained in performing the PIPP.

  Immediately after application of nasal CPAP (approx 5 min)

Secondary Outcomes (4)

• Salivary cortisol

  30 minute after application of nasal CPAP

• Duration of first cry

  Immediately after application of nasal CPAP (approx 5 min)

• Possible adverse effects to lidocaine

  Within 72 hours of application of topical lidocaine gel

• Nasal trauma

  24 hours after application of nasal CPAP

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine 2% Gel

Control

NO INTERVENTION

No topical lidocaine will be used prior to application of nasal CPAP

Interventions

Lidocaine 2% Gel DRUG

Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP

Also known as: Xylocaine jelly 2%

Lidocaine

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Neonatal Intensive Care Unit, Mansoura University Children Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (4)

• 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.

  PMID: 25053125 BACKGROUND

• 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.

  PMID: 10654977 BACKGROUND

• 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.

  PMID: 8086725 BACKGROUND

• 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.

  PMID: 14970141 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Gels

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Hesham E Abdel-Hady, MD, PhD

  Mansoura University Children Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

EG (1)