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

Primary Purpose

Other Preterm Infants

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine 2% Gel
Sponsored by
Mansoura University Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Other Preterm Infants focused on measuring Topical Lidocaine, Nasal CPAP, Pain, Preterm Infants, Salivary cortisol

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept 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

Sites / Locations

  • Neonatal Intensive Care Unit, Mansoura University Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lidocaine

Control

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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
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
Nasal trauma
The nose of enrolled infants will be assessed for any sign of injury 24 hours after application of nasal CPAP

Full Information

First Posted
October 16, 2014
Last Updated
April 12, 2015
Sponsor
Mansoura University Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02268968
Brief Title
Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal CPAP Continuous Positive Airway Pressure
Official Title
Use of Topical Lidocaine to Reduce Pain in Preterm Infants Receiving Nasal Contiuous Positive Airway Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University Children Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Preterm Infants
Keywords
Topical Lidocaine, Nasal CPAP, Pain, Preterm Infants, Salivary cortisol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
No Intervention
Arm Description
No topical lidocaine will be used prior to application of nasal CPAP
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% Gel
Other Intervention Name(s)
Xylocaine jelly 2%
Intervention Description
Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP
Primary Outcome Measure Information:
Title
The Premature Infant Pain (PIPP) Scale
Description
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.
Time Frame
Immediately after application of nasal CPAP (approx 5 min)
Secondary Outcome Measure Information:
Title
Salivary cortisol
Description
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).
Time Frame
30 minute after application of nasal CPAP
Title
Duration of first cry
Description
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
Time Frame
Immediately after application of nasal CPAP (approx 5 min)
Title
Possible adverse effects to lidocaine
Description
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
Time Frame
Within 72 hours of application of topical lidocaine gel
Title
Nasal trauma
Description
The nose of enrolled infants will be assessed for any sign of injury 24 hours after application of nasal CPAP
Time Frame
24 hours after application of nasal CPAP

10. Eligibility

Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hesham E Abdel-Hady, MD, PhD
Organizational Affiliation
Mansoura University Children Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit, Mansoura University Children Hospital
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
25053125
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.
Results Reference
background
PubMed Identifier
10654977
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.
Results Reference
background
PubMed Identifier
8086725
Citation
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.
Results Reference
background
PubMed Identifier
14970141
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. doi: 10.1093/bja/aeh522. No abstract available.
Results Reference
background

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

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