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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT02268968
• Date of registration: 16/10/2014
• Prospective Registration: No
• Primary sponsor: Mansoura University Children Hospital
• Public title: Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal CPAP Continuous Positive Airway Pressure
• Scientific title: Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal Contiuous Positive Airway Pressure
• Date of first enrolment: October 2013
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02268968
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Egypt

Contacts

• Name: Hesham E Abdel-Hady, MD, PhD
• Affiliation: Mansoura University Children Hospital

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 28 Days
Gender: Both

Health Condition(s) or Problem(s) studied

Other Preterm Infants

Intervention(s)

Drug: Lidocaine 2% Gel

Primary Outcome(s)

The Premature Infant Pain (PIPP) Scale [Time Frame: Immediately after application of nasal CPAP (approx 5 min)]

Secondary Outcome(s)

Nasal trauma [Time Frame: 24 hours after application of nasal CPAP]

Duration of first cry [Time Frame: Immediately after application of nasal CPAP (approx 5 min)]

Possible adverse effects to lidocaine [Time Frame: Within 72 hours of application of topical lidocaine gel]

Salivary cortisol [Time Frame: 30 minute after application of nasal CPAP]

Secondary ID(s)

MS 012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors