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

Trial Summary

What is the purpose of this trial?

The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.

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 data supports the effectiveness of the treatment 24% Sucrose, Sweet-Ease, SweetUms, 24% Sucrose Solution for infant pain relief?

Research shows that sweet solutions like sucrose can help reduce pain in infants during minor procedures, such as blood sampling or immunizations. These solutions are given by mouth and have been found to effectively lessen crying and pain responses in newborns. ^{1 2 3 4 5}

Is sugar water safe for infant pain relief?

Sugar water, often used in forms like 24% sucrose solution, is generally considered safe for infants when used in small amounts for pain relief during procedures. It has been widely studied and used in clinical settings without significant safety concerns. ^{6 7 8 9 10}

How does the treatment 24% Sucrose differ from other treatments for infant pain relief?

The 24% Sucrose solution is unique because it is a sweet liquid given orally to infants to provide short-term pain relief during minor procedures, like immunizations. It is supported by strong evidence of effectiveness and has no serious side effects, making it a safe and simple option compared to other treatments. ^{1 2 5 11 12}

Research Team

Nikolaus E. Wolter, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sucrose analgesia for minor procedures in newborn infants. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analyses of nonsucrose sweet solutions for pain relief in neonates. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of non-sucrose sweet tasting solution on neonatal heel prick responses. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Glucose or sucrose as an analgesic for newborns: a randomised controlled blind trial. [2014]

5. Australia pubmed.ncbi.nlm.nih.gov

Sweet solutions for procedural pain in infants. [2013]

6. England pubmed.ncbi.nlm.nih.gov

"A spoonful of sugar helps the medicine go down": bitter masking by sucrose among children and adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Nonnutritive Sweeteners in Breast Milk. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Critical review of the current literature on the safety of sucralose. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Development and validation of an LC-MS/MS method for the quantification of artificial sweeteners in human matrices. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Reduction of pain response in premature infants using intraoral sucrose. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

Oral sucrose administration to reduce pain response during immunization in 16-19-month infants: a randomized, placebo-controlled trial. [2021]