CClinicalTrials.gg
Status unknownNCT00213213Updated Mar 15, 2010

Using Sugar Water to Relieve Pain in Infants

An interventional study of Sucrose in Pain, Infant, Newborn and Diabetes, sponsored by The Hospital for Sick Children. Status unknown at 1 site in Canada. Open to participants aged 1 Day to 3 Days. Per ClinicalTrials.gov, last updated 2010-03-15.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
1 Day to 3 Days
Sex
All
01

Study summary

This study will examine the safety and effectiveness of sugar water to relieve pain in newborn infants during painful blood tests and injections. Infants of diabetic mothers who receive repeated blood tests will be compared to infants of healthy mothers who receive routine painful procedures.

We believe that administration of sucrose analgesia for every painful cutaneous procedure performed after delivery will result in less pain during the newborn infant screening test.

02

Conditions studied

  • Pain
  • Infant, Newborn
  • Diabetes

Keywords

  • sucrose
  • analgesia
  • pain
  • neonates
  • diabetes
03

In context

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 3 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • healthy newborn infants ≥36 weeks gestation
  • infants born to mothers with diabetes (type 1, type 2, or gestational diabetes that is diet-controlled or insulin-dependent)and infants born to mothers without diabetes

Exclusion criteria

Exclusion Criteria:

  • Admission to the neonatal intensive care unit
  • plan to undergo circumcision during the study period
  • major congenital or neurological anomalies
  • clinical diagnosis of birth asphyxia or seizures
  • receiving analgesics or sedatives
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
240 participants

Interventions

  • DrugSucrose
06

What researchers measure

Primary outcomes

  1. - Infant pain score during the newborn screening test, assessed by the Premature Infant Pain Profile (PIPP), or individual parameters of PIPP (facial grimace, heart rate, oxygen saturation)

Secondary outcomes

  1. (effectiveness):

  2. - Effectiveness of sucrose for repeated heel lances

  3. - Effectiveness of sucrose in decreasing anticipatory pain responses during venipuncture

  4. - Effectiveness of sucrose in decreasing pain response during Vitamin K injection

  5. - Determination of relationship between painful procedures and infant response during routine care procedures

  6. (safety):

  7. - Incidence of vomiting during administration of sucrose

  8. - Oxygen saturation during administration of sucrose

  9. - Serum Glucose concentrations in infants of diabetic mothers

07

Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5G 1X5, Canada
08

References and documents

Publications

  • Taddio A, Shah V, Hancock R, Smith RW, Stephens D, Atenafu E, Beyene J, Koren G, Stevens B, Katz J. Effectiveness of sucrose analgesia in newborns undergoing painful medical procedures. CMAJ. 2008 Jul 1;179(1):37-43. doi: 10.1503/cmaj.071734. PubMed 18591525 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00213213
Lead sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
First posted
Sep 21, 2005
Start date
Jul 2003
Completion
Jul 2005
Last update
Mar 15, 2010

Study contacts

Anna Taddio, PhD
principal investigator · The Hospital for Sick Children, Toronto Canada
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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