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Sugar Water for Infant Pain Relief

N/A

Recruiting

Led By Nikolaus E. Wolter, MD

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient <12 months of age

Be younger than 18 years old

Must not have

Infants who have received topical anesthesia (topical decongestant/anesthetic spray)

Infants <37 weeks corrected gestational age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 months

Summary

This trial will test if giving babies sugar water with 24% sucrose can help reduce their pain during medical procedures called scopes.

Who is the study for?

This trial is for babies who need a nasolaryngoscopy, which is a scope test to look inside the nose and throat. There are no specific inclusion or exclusion criteria provided, so it's likely open to any infant needing this procedure.

What is being tested?

The study is testing if giving babies sugar water with 24% sucrose before a nasolaryngoscopy can help reduce their pain compared to using sterile water (which has no sugar).

What are the potential side effects?

Since the intervention involves only sugar water or sterile water, side effects might be minimal but could include mild discomfort from taste or potential upset stomach.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am under 1 year old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My infant has received a numbing spray for treatment.

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My baby was born before 37 weeks of pregnancy.

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My infant shows reduced alertness or delayed physical development and reacts less to pain.

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My child is not enrolled because I did not consent to random treatment selection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Scores

Secondary study objectives

Caregiver impression

Crying time

Duration of clinic visit

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sucrose solutionExperimental Treatment1 Intervention

Participants will be given sugar water which contains 24% sucrose. As per pharmacy at The Hospital for Sick Children, Sucrose is not classified as a drug as per Health Canada.

Group II: Sterile waterPlacebo Group1 Intervention

Participants will be given sterile water which does not contain sugar and is used as a placebo

0 / 5Eligibility criteria met