Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture

Study Overview
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Brief Summary
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The objective of this study is to determine the relative efficacy of sucrose, liposomal lidocaine, and sucrose plus liposomal lidocaine, on reducing pain during venipuncture in newborn infants.

Detailed Description
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Despite the fact that modern medical practice is greatly advanced, pain is inflicted on all Canadian newborn infants in the first days and months of life from blood tests, injections and cannulations designed to prevent, diagnose or manage medical conditions. Procedural pain in newborn infants is a significant burden to infants, their parents, healthcare workers, and society at large. This study proposes a large randomized controlled trial to determine the optimal analgesic regimen for procedural pain using methods that can be easily implemented in clinical practice. We will study liposomal lidocaine cream and sucrose oral liquid, used alone, or together, to manage procedural pain. Liposomal lidocaine is a relatively new anaesthetic formulation ideally suited for young infants due to the established role of lidocaine in neonatal clinical medicine. Sucrose (sugar water) reduces pain responses and is promoted in consensus guidelines developed by pain experts. However, it is perceived by many front-line clinicians to be simply a comforting agent rather than a true analgesic. Studying liposomal lidocaine and sucrose together is important since the combination may prove superior to either agent alone, and may even prevent or abolish pain from clinical procedures.

Official Title
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Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture: A Randomized Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: 24% Sucrose Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy newborn infants ≥ 37 weeks gestational age. Exclusion Criteria: neonatal intensive care unit (NICU) admission asphyxia, seizures major birth defect (heart, brain, genetic syndrome) circumcised during study receiving analgesia/sedatives.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>This group will receive lidocaine and sucrose placebo (water). | Drug: Lidocaine<br>* 1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.<br>* Other names: Maxilene 4;|
| Active Comparator: 2<br>This group will receive lidocaine placebo and sucrose. | Drug: 24% Sucrose Solution<br>* 2ml of 24% sucrose will be administered 2 minutes prior to venipuncture<br>* Other names: TootSweet;|
| Active Comparator: 3<br>This group will receive lidocaine and sucrose. | Drug: Lidocaine<br>* 1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.<br>* Other names: Maxilene 4;Drug: 24% Sucrose Solution<br>* 2ml of 24% sucrose will be administered 2 minutes prior to venipuncture<br>* Other names: TootSweet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant pain during venipuncture as assessed by facial grimacing response. |  | During venipuncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale scores |  | During venipuncture | 
| Cry duration |  | During venipuncture | 
| Heart rate |  | During venipuncture | 
| Number of attempts until procedure completion |  | From first needle poke to completion | 
| Endomorphins-1,-2 levels |  | Before and 10 minutes after sucrose/sucrose placebo administration | 
| Procedure duration |  | From first needle poke to completion | 
| Lidocaine levels |  | 5-15 minutes after the study cream is removed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, pain, infants, newborn screening, venipuncture, lidocaine, sucrose