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

Phase 1

Completed

• Conditions: Other Preterm Infants
• Interventions: Drug: Lidocaine 2% Gel

• Registration Number: NCT02268968
• Lead Sponsor: Mansoura University Children Hospital

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-20
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-12
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine 2% Gel	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

Primary Outcome Measures

Name	Time	Method
The Premature Infant Pain (PIPP) Scale	Immediately after application of nasal CPAP (approx 5 min)	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.

Secondary Outcome Measures

Name	Time	Method
Possible adverse effects to lidocaine	Within 72 hours of application of topical lidocaine gel	CNS side effects as irritability, nervousness, confusion, vomiting, twitching, tremors, convulsions, unconsciousness, respiratory depression, and arrest.; Cardiovascular side effects: bradycardia, hypotension, and cardiovascular collapse, and cardiac arrest.; Allergic: urticaria, edema, or anaphylactic reactions
Nasal trauma	24 hours after application of nasal CPAP	The nose of enrolled infants will be assessed for any sign of injury 24 hours after application of nasal CPAP
Salivary cortisol	30 minute after application of nasal CPAP	Salivary samples will be obtained 30 minutes after application of nasal CPAP using sterile single channel 500 μl pipette (Dragon Laboratory Instruments Limited, Beijing 101318 China). After collection, the saliva wll be centrifuged, frozen and stored at -70°C. The samples will later analysed using ELISA technique; IBL kits (IBL International GmbH, Flughafenstr. 52A, 22335 Hamburg, Germany).
Duration of first cry	Immediately after application of nasal CPAP (approx 5 min)	The duration of the first cry will be defined as audible distressed vocalizations with a continuous pattern before a quiet interval of 5 seconds soon after application of nasal CPAP

Trial Locations

Locations (1)

Neonatal Intensive Care Unit, Mansoura University Children Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt