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NCT Number: NCT02268968

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

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

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Key information

Conditions

Other Preterm Infants Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Neonatal Intensive Care Unit, Mansoura University Children Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine 2% Gel

Drug

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

Other names: Xylocaine jelly 2%

Primary outcomes

  1. The Premature Infant Pain (PIPP) Scale

    Time frame: 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 outcomes

  1. Salivary cortisol

    Time frame: 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).

  2. Duration of first cry

    Time frame: 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

  3. Possible adverse effects to lidocaine

    Time frame: 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

  4. Nasal trauma

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 20, 2014
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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