We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01544946
First Posted: March 6, 2012
Last Update Posted: December 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Serge Gouin, St. Justine's Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Serge Gouin, St. Justine's Hospital:

Primary Outcome Measures:
  • Difference in pains scores related to nasopharyngeal aspiration [ Time Frame: one minute ]

Secondary Outcome Measures:
  • Difference in pain scores related to nasopharyngeal aspiration [ Time Frame: 3 minutes ]

Enrollment: 80
Study Start Date: February 2012
Study Completion Date: November 2015
Primary Completion Date: November 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544946


Locations
Canada, Quebec
CHU Ste-Justine
Montreal, Quebec, Canada, H3T1C5
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Principal Investigator: Serge Gouin, MDCM, FRCPC St. Justine's Hospital
  More Information

Responsible Party: Serge Gouin, Associate Professor, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT01544946     History of Changes
Other Study ID Numbers: Sucrose3415
First Submitted: February 29, 2012
First Posted: March 6, 2012
Last Update Posted: December 22, 2015
Last Verified: December 2015

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