Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborns Undergoing Venipuncture
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Lidocaine Drug: 24% Sucrose Solution |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of Topical Liposomal Lidocaine and Oral Sucrose for Treatment of Pain in Newborn Infants Undergoing Venipuncture: A Randomized Controlled Trial |
- Infant pain during venipuncture as assessed by facial grimacing response. [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]
- Visual Analog Scale scores [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]
- Cry duration [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]
- Heart rate [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]
- Number of attempts until procedure completion [ Time Frame: From first needle poke to completion ] [ Designated as safety issue: No ]
- Endomorphins-1,-2 levels [ Time Frame: Before and 10 minutes after sucrose/sucrose placebo administration ] [ Designated as safety issue: No ]
- Procedure duration [ Time Frame: From first needle poke to completion ] [ Designated as safety issue: No ]
- Lidocaine levels [ Time Frame: 5-15 minutes after the study cream is removed ] [ Designated as safety issue: No ]
| Enrollment: | 330 |
| Study Start Date: | August 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
This group will receive lidocaine and sucrose placebo (water).
|
Drug: Lidocaine
1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
Other Name: Maxilene 4
|
|
Active Comparator: 2
This group will receive lidocaine placebo and sucrose.
|
Drug: 24% Sucrose Solution
2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
Other Name: TootSweet
|
|
Active Comparator: 3
This group will receive lidocaine and sucrose.
|
Drug: Lidocaine
1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
Other Name: Maxilene 4
Drug: 24% Sucrose Solution
2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
Other Name: TootSweet
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 7 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Mount Sinai Hospital | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Principal Investigator: | Anna Taddio, PhD | The Hospital for Sick Children, Toronto Canada |
More Information
No publications provided
| Responsible Party: | Anna Taddio/Principal Investigator, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00519207 History of Changes |
| Other Study ID Numbers: | 1000010747 |
| Study First Received: | August 20, 2007 |
| Last Updated: | July 18, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
pediatrics pain infants newborn screening |
venipuncture lidocaine sucrose |
Additional relevant MeSH terms:
|
Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013