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

Other Preterm Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268968
• Other study ID #: MS 012
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2014
• Last updated: April 12, 2015
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Mansoura University Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Other Preterm Infants
• Premature Birth

Intervention

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

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit, Mansoura University Children Hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Children Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Bendixen D, Halvorsen AC, Hjelt K, Flachs H. Lignocaine gel used for lubrication of intranasal and endotracheal tubes in premature neonates. Acta Paediatr. 1994 May;83(5):493-7. — View Citation

Britto CD, Rao Pn S, Nesargi S, Nair S, Rao S, Thilagavathy T, Ramesh A, Bhat S. PAIN--perception and assessment of painful procedures in the NICU. J Trop Pediatr. 2014 Dec;60(6):422-7. doi: 10.1093/tropej/fmu039. Epub 2014 Jul 21. — View Citation

Lillieborg S, Otterbom I, Ahlen K. Topical anaesthesia in neonates, infants and children. Br J Anaesth. 2004 Mar;92(3):450; author reply 450-1. — View Citation

Prevention and management of pain and stress in the neonate. American Academy of Pediatrics. Committee on Fetus and Newborn. Committee on Drugs. Section on Anesthesiology. Section on Surgery. Canadian Paediatric Society. Fetus and Newborn Committee. Pediatrics. 2000 Feb;105(2):454-61. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	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	Yes
Secondary	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	Yes