Pain
Conditions
Keywords
pediatrics, pain, infants, newborn screening, venipuncture, lidocaine, sucrose
Brief summary
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
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.
Interventions
DRUGLidocaine
1g of liposomal lidocaine will be administered 30-40 minutes prior to venipuncture and occluded by a dressing.
2ml of 24% sucrose will be administered 2 minutes prior to venipuncture
Sponsors
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infant pain during venipuncture as assessed by facial grimacing response. | During venipuncture |
Secondary
| Measure | Time frame |
|---|---|
| Cry duration | During venipuncture |
| Heart rate | During venipuncture |
| Number of attempts until procedure completion | From first needle poke to completion |
| Visual Analog Scale scores | During venipuncture |
| Procedure duration | From first needle poke to completion |
| Lidocaine levels | 5-15 minutes after the study cream is removed |
| Endomorphins-1,-2 levels | Before and 10 minutes after sucrose/sucrose placebo administration |
Countries
Canada
Outcome results
None listed