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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal Contiuous Positive Airway Pressure

Conditions
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Other Preterm Infants

Intervention / Treatment
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* Drug: Lidocaine 2% Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine<br>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<br>* Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP<br>* Other names: Xylocaine jelly 2%;|
| No Intervention: Control<br>No topical lidocaine will be used prior to application of nasal CPAP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cortisol | 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). | 30 minute after application of nasal CPAP | 
| Duration of first cry | 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 | Immediately after application of nasal CPAP (approx 5 min) | 
| Possible adverse effects to lidocaine | 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 | Within 72 hours of application of topical lidocaine gel | 
| Nasal trauma | The nose of enrolled infants will be assessed for any sign of injury 24 hours after application of nasal CPAP | 24 hours after application of nasal CPAP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal CPAP, Pain, Topical Lidocaine, Preterm Infants, Salivary cortisol