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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by St. Justine's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Serge Gouin, St. Justine's Hospital
ClinicalTrials.gov Identifier:
NCT01544946
First received: February 29, 2012
Last updated: March 5, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: 88% sucrose po
Drug: placebo po
Phase 4

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: A Randomized Double-blind Trial Comparing the Effect on Pain of an Oral Sucrose Solution Versus Placebo in Children 1 to 3 Months Old Needing Nasopharyngeal Aspiration

Resource links provided by NLM:


Further study details as provided by St. Justine's Hospital:

Primary Outcome Measures:
  • Difference in pains scores related to nasopharyngeal aspiration [ Time Frame: one minute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in pain scores related to nasopharyngeal aspiration [ Time Frame: 3 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 76
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sucrose po Drug: 88% sucrose po
88% sucrose solution (Syrup B.P.)
Placebo Comparator: placebo po Drug: placebo po
sterile water

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544946

Contacts
Contact: Serge Gouin, MDCM, FRCPC 5143454931 ext 3498 sergegouin@aol.com

Locations
Canada, Quebec
CHU Ste-Justine Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Serge Gouni, MDCM, FRCPC    5143454931 ext 3498    sergegouin@aol.com   
Principal Investigator: Serge Gouin, MDCM, FRCPC         
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Serge Gouin, MDCM, FRCPC CHU Ste-Justine
  More Information

No publications provided

Responsible Party: Serge Gouin, Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01544946     History of Changes
Other Study ID Numbers: Sucrose3415
Study First Received: February 29, 2012
Last Updated: March 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Justine's Hospital:
pediatrics
emergency medicine
pain
nasopharyngeal aspiration

ClinicalTrials.gov processed this record on July 23, 2014