Overview

Trial of an Oral Sucrose Solution Versus Placebo in Children 1 to 3 Months Old Needing Nasopharyngeal Aspiration

Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
Summary
Background: Early recognition and treatment of pain among children is important for their cognitive development and their future response to pain throughout their life. Oral sweet solutions have been accepted as effective pain reducing agents for procedures in the neonatal population. To date, there have been a limited number of published clinical trials in an emergency setting studying this type of intervention among infants undergoing venous puncture and bladder catheterization. These studies have reported conflicting results. No previous studies have evaluated the utilization of sucrose to manage pain during nasopharyngeal aspiration. Objective: To compare the efficacy of an oral sucrose solution versus placebo in reducing pain in children one to three months of age during nasopharyngeal aspiration in the Emergency Department.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
St. Justine's Hospital
Criteria
Inclusion Criteria:

- Infants from one to three months (one month or more but less than three months old) of
actual age (not corrected) requiring a nasopharyngeal aspiration as a part of their
planned ED management during weekdays from 8h to 16h.

Exclusion Criteria:

- Preterm infants (i.e. born <37 weeks)

- Chronic cardio-pulmonary condition

- Assisted ventilation (such as tracheostomy or oxygen dependance)

- Technology dependant (such as enteral feeding tubes)

- Oropharyngeal malformation or dysfunction (such as cleft palate or micrognatia)

- Previous participation in this study

- Painful procedures in the preceding 60 minutes (bladder catheterization, vesical
puncture, lumbar puncture, capillary blood tests)

- Parental language barrier (French and/or English)