Sugar Water for Infant Pain Relief

Overseen By Mary-Elizabeth Vanderpost, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must not be taking: Topical anesthetics

Disqualifiers: Age >12 months, Carbohydrate intolerance, Severe respiratory distress, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Single visit

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sugar water with 24% sucrose can reduce pain in infants during a flexible nasolaryngoscopy, an examination of the airways. Researchers will compare the effects of sugar water to plain sterile water to determine which is more effective. The trial is open to babies under 12 months who have appointments for this specific exam at the Hospital for Sick Children. Infants must be accompanied by caregivers who agree to participate. As an unphased trial, this study allows caregivers to contribute to research that could enhance pain management for infants during medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this 24% sucrose solution is safe for infants?

Previous studies have shown that a 24% sugar water solution is safe for babies. This solution has been widely researched and helps reduce discomfort in infants. One study found strong evidence that 24% sugar water effectively eases pain when given with a pacifier or in small amounts. No major safety concerns have been reported with its use. However, it should be used only when necessary, as the long-term effects of frequent use are not fully understood. Overall, 24% sugar water is generally well-tolerated in babies up to 18 months old. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike other treatments for infant pain relief, which often involve topical anesthetics or oral medications, this approach uses a simple sucrose solution, commonly known as sugar water. Researchers are excited about using 24% sucrose because it is a non-pharmacological option that is easy to administer and has minimal side effects. The sucrose solution acts by triggering the release of natural pain-relief endorphins in the brain, offering a gentle and effective way to soothe infants without the need for more complex medications.

What evidence suggests that 24% sucrose solution might be an effective treatment for infant pain relief?

Research has shown that a 24% sugar water solution can effectively reduce pain in babies during medical procedures. In this trial, participants in one arm will receive this sugar water solution, which studies have shown significantly lessens pain, as measured by a special pain scale for infants. One study showed that this solution noticeably reduced pain during heel pricks in newborns. Even a small amount of 24% sugar water, given with a pacifier before a procedure, eased pain. These findings suggest that sugar water can be a helpful and simple way to comfort babies during uncomfortable procedures. Participants in the other arm will receive sterile water as a placebo comparator. ^{5 6 7 8 9}

Who Is on the Research Team?

Nikolaus E. Wolter, MD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Scheduled for an appointment with Dr. Nikolaus Wolter or Dr. Jennifer Siu, who are Staff Pediatric Otolaryngologists at the Hospital for Sick Children, or Meghan Tepsich, a complex airway Nurse Practitioner at SickKids

I am under 1 year old.

Requiring flexible nasolaryngoscopy for diagnostic purposes

Exclusion Criteria

My baby was born before 37 weeks of pregnancy.

I am older than 12 months.

Infants presenting with conditions in which flexible nasolaryngoscopy is contraindicated: Severe respiratory distress, Post-palliative systemic artery to pulmonary artery shunt, Single ventricle congenital heart disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either sterile water or a 24% sucrose solution during flexible nasolaryngoscopy to assess pain management

Single visit

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain scores, heart rate, and other secondary outcomes after the procedure

up to 7 months

What Are the Treatments Tested in This Trial?

Interventions

• 24% Sucrose

Trial Overview 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).

How Is the Trial Designed?

Group I: Sucrose solution Experimental Treatment 1 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 water Placebo Group 1 Intervention

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

24% Sucrose is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as 24% Sucrose Solution for:

• Procedural pain management in infants

Approved in United States as Sweet-Ease for:

• Pain relief during minor medical procedures in infants

Approved in Canada as 24% Sucrose Solution for:

• Procedural pain management in neonates and infants

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

A study involving 537 healthy infants aged 16-19 months showed that a 75% sucrose solution significantly reduced crying times and pain scores during immunization injections compared to a control group and a 25% sucrose solution.

The findings suggest that sucrose is a safe and effective method to alleviate procedural pain in infants beyond the newborn period, making it clinically useful for reducing distress during vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral sucrose administration to reduce pain response during immunization in 16-19-month infants: a randomized, placebo-controlled trial. Yilmaz, G., Caylan, N., Oguz, M., et al.[2021]

A systematic review of 38 studies involving 3785 neonates found that glucose solutions (20% to 30%) significantly reduce pain scores during minor procedures like heel lances and venipunctures, making them effective alternatives to sucrose for pain relief.

Infants receiving glucose solutions showed a notable decrease in crying after venipuncture, with a risk difference indicating that glucose can effectively alleviate pain in neonates during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analyses of nonsucrose sweet solutions for pain relief in neonates. Bueno, M., Yamada, J., Harrison, D., et al.[2022]

A comprehensive review of the literature indicates that sucralose, a non-caloric sweetener, is safe for consumption, with studies showing no significant adverse effects on growth, reproduction, or overall health in both animals and humans.

Research has consistently shown that the intake levels of sucralose across various population groups, including children with special dietary needs, remain well below the acceptable daily intake, supporting its safety as a sugar alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical review of the current literature on the safety of sucralose. Magnuson, BA., Roberts, A., Nestmann, ER.[2022]

A study of breast milk from 20 lactating women found that nonnutritive sweeteners (NNS) like saccharin, sucralose, and acesulfame-potassium were present in 65% of samples, indicating that nursing infants are often exposed to these substances.

While saccharin is the only NNS detected in breast milk, the safety and potential clinical implications of early exposure to NNS through breastfeeding remain unclear, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonnutritive Sweeteners in Breast Milk. Sylvetsky, AC., Gardner, AL., Bauman, V., et al.[2019]

A new sensitive method using liquid chromatography-tandem mass spectrometry was developed to measure artificial sweeteners like acesulfame, cyclamate, saccharin, and sucralose in human plasma, umbilical cord blood, amniotic fluid, and breast milk, which is crucial for understanding their effects during pregnancy and lactation.

The method demonstrated high accuracy and precision, making it suitable for clinical studies to explore the safety and impact of artificial sweeteners on child development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of an LC-MS/MS method for the quantification of artificial sweeteners in human matrices. Greibe, E., Leth-Møller, M., Stampe, S., et al.[2022]

In a randomized double-blind trial involving 140 healthy newborns, 33% and 50% glucose solutions were found to be the most effective in reducing pain response during heelstick procedures, as indicated by heart rate measurements.

The study suggests that sweet solutions like glucose can serve as a safe, effective, and inexpensive method for providing analgesia during minor invasive procedures in newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose or sucrose as an analgesic for newborns: a randomised controlled blind trial. Guala, A., Pastore, G., Liverani, ME., et al.[2014]

Adding sucrose to bitter-tasting drugs significantly reduces their bitterness perception in both children and adults, making medications more palatable.

In adults, those with a sensitive sweet taste receptor experienced a greater reduction in bitterness for certain compounds like caffeine and quinine, highlighting the role of genetics in taste perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"A spoonful of sugar helps the medicine go down": bitter masking by sucrose among children and adults. Mennella, JA., Reed, DR., Mathew, PS., et al.[2022]

Intraoral sucrose and other sweet-tasting solutions can effectively reduce pain in newborns during minor procedures, as indicated by decreased crying time, lower heart rate increases, and reduced pain scale ratings.

A sucrose solution of 0.5 g has been shown to provide effective pain relief without any reported adverse effects, making it a safe option for managing pain in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sucrose analgesia for minor procedures in newborn infants. Masters-Harte, LD., Abdel-Rahman, SM.[2017]

In a study involving 15 healthy premature infants, administering 1 ml of 25% sucrose solution before a painful heel lance significantly reduced their pain response, as measured by cry duration and facial expressions.

The results suggest that sucrose can effectively act as a pain reliever for premature infants during minor medical procedures, indicating its potential use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of pain response in premature infants using intraoral sucrose. Ramenghi, LA., Wood, CM., Griffith, GC., et al.[2019]

Oral sweet solutions like sucrose or glucose are effective for providing short-term pain relief during minor procedures, such as immunizations, in infants up to 12 months old.

This method of analgesia has strong evidence supporting its efficacy (NHMRC Level I) and has not been associated with any serious adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sweet solutions for procedural pain in infants. [2013]

The review evaluates four intense sweeteners—acesulfame-K, aspartame, cyclamate, and saccharin—highlighting their extensive toxicity data assessed by regulatory authorities, which is crucial for determining safe consumption levels.

Each sweetener has a calculated acceptable daily intake (ADI) based on a no adverse effect level from animal studies, with a significant safety factor applied to ensure human safety, as discussed in relation to guidelines from the Scientific Committee for Food in 1985.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptable daily intake and the regulation of intense sweeteners. Renwick, AG.[2013]

In a study involving 60 infants, a sweet-tasting solution labeled as 'sugar free' was found to significantly reduce crying time and pain scores during heel prick blood sampling, indicating its effectiveness in alleviating neonatal pain.

The analgesic effects of the sweet-tasting solution were comparable to those of concentrated sucrose solutions, suggesting it could be a viable alternative for pain management in infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of non-sucrose sweet tasting solution on neonatal heel prick responses. Ramenghi, LA., Griffith, GC., Wood, CM., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9941618/

The effectiveness of repeated sucrose for procedural pain in ... Infants received 24% sucrose (0.12 ml) prior to all painful procedures. The Premature Infant Pain Profile – Revised (PIPP-R) was used at 30 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01438008

Pilot Study of Sucrose to Reduce Pain in Sick Babies Small amounts of sweet tasting sugar water reduces pain in babies during painful blood tests and injections. The investigators do not know if sugar also ...

3. clinmedjournals.org clinmedjournals.org/articles/ijpr/international-journal-of-pediatric-research-ijpr-10-131.php?jid=ijpr

Effectiveness of Sucrose Analgesia in Term Neonates for ... 24% Sucrose reduced pain to a considerable level (NIPS < 4) in neonates at 1 min and at 3 minutes when compared to 10% dextrose for heel lance. Similarly, 24% ...

4. nature.com nature.com/articles/s41372-025-02423-w

Sucrose or glucose compared to breast milk for pain ... Moreover, as little as 0.1 ml of 24% sucrose, along with a pacifier, 2 min before a painful procedure, is efficacious in reducing procedural ...

5. publications.aap.org publications.aap.org/pediatrics/article/130/5/918/32407/Sucrose-for-Procedural-Pain-Management-in-Infants

Sucrose for Procedural Pain Management in Infants Although results of a meta-analysis of 4 studies conducted during eye examination showed sucrose significantly reduced Premature Infant Pain ...

6. int-bio.com int-bio.com/developmental-care/calming-and-soothing/sweet-ease-sucrose-solution/

Sweet-Ease Natural Sucrose Solution for Infants Sweet-Ease Sucrose Solution has been extensively studied and is considered safe for use in infants. In many cases, Sweet-Ease has been shown to be more ...

7. laborie.com laborie.com/product/sweetums-24-sucrose/

SweetUms™ 24% Sucrose Range SweetUms is a 24% Sucrose Solution to help calm and soothe babies. 24% Oral Sucrose has been widely studied and proven to help reduce discomfort in infants.

8. childrens.health.qld.gov.au childrens.health.qld.gov.au/__data/assets/pdf_file/0032/179681/paediatric-medication-administration-Sucrose-24-percent.pdf

Paediatric Medication Administration: Sucrose 24% Sucrose can be used up to 18 months of age. It is important to note that breastmilk can also be used for procedural pain and should be considered in neonates.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27420164/

Sucrose for analgesia in newborn infants undergoing painful ... There was high-quality evidence for the beneficial effect of sucrose (24%) with non-nutritive sucking (pacifier dipped in sucrose) or 0.5 mL of ...