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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | 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 |
|
| Control | No Intervention | No topical lidocaine will be used prior to application of nasal CPAP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine 2% Gel | Drug | Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP |
|
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hesham E Abdel-Hady, MD, PhD | Mansoura University Children Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal Intensive Care Unit, Mansoura University Children Hospital | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25053125 | Background | 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. | |
| 10654977 | Background | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D005782 | Gels |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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 |
| 8086725 | Background | 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. doi: 10.1111/j.1651-2227.1994.tb13065.x. |
| 14970141 | Background | 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. doi: 10.1093/bja/aeh522. No abstract available. |
| Aniline Compounds |
| D000588 | Amines |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |