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

NCT01544946 | Completed Phase 4

• 1 other identifier: Sucrose3415
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

pediatrics; emergency medicine; pain; nasopharyngeal aspiration

Outcome Measures

Primary Outcomes (1)

• Difference in pains scores related to nasopharyngeal aspiration

  one minute

Secondary Outcomes (1)

• Difference in pain scores related to nasopharyngeal aspiration

  3 minutes

Study Arms (2)

sucrose po

EXPERIMENTAL

Drug: 88% sucrose po

placebo po

PLACEBO COMPARATOR

Drug: placebo po

Interventions

88% sucrose po DRUG

88% sucrose solution (Syrup B.P.)

sucrose po

placebo po DRUG

sterile water

placebo po

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Ste-Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serge Gouin, MDCM, FRCPC

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 6, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

CA (1)