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

Mansoura University Children Hospital

Status and phase: Completed; Phase 1

Conditions: Other Preterm Infants

Treatments: Drug: Lidocaine 2% Gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02268968

MS 012

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Lidocaine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine 2% Gel

Control

No Intervention group

Description:

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