Sucrose Practices for Pain in Neonates Part B (SPiN)

The Hospital for Sick Children

Status

Completed

Conditions

Pain

Treatments

Other: 24% Sucrose Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT02725814

REB1000051066

126167 (Other Grant/Funding Number)

Details and patient eligibility

About

Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing babies' pain during painful procedures. Unfortunately, sucrose is not used as often as it could be to reduce babies' pain. This may be due to lack of certainty about the least effective amount of sucrose to use and concerns about the long-term effects of repeated use of sucrose on infant development. Factors within the hospital units where babies receive care may also influence caregivers' decisions to use sucrose. In this research the investigators will conduct two main studies. In the first study the investigators determined the lowest amount of sucrose needed to manage babies' pain effectively. In the second study the investigators will explore (a) if this amount of sucrose can manage pain when it is used repeatedly for all painful procedures while the baby is hospitalized and (b) whether consistent use of sucrose influences the development of babies when they are 18 and 36 months old. During the second study, the investigators will also examine the hospital units where the babies receive care. They will look at staff support for research, time and resources and other factors that promote and prevent sucrose use. The results of these studies will be used to determine the best management of babies' pain during painful procedures in hospitals to achieve the best outcomes.

Enrollment

172 patients

Sex

All

Ages

Under 10 days old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

less than 32 weeks gestational age at birth
admitted to the neonatal intensive care unit (NICU)
expected to have heel lances for routine blood tests
yet to reach 10 days of life at the time of study enrollment.

Exclusion:

known hypersensitivity to sucrose, corn, corn products or any component of the formulation
short-bowel syndrome
carbohydrate intolerance
unable to swallow/absent gag reflex (e.g., pharmacologically muscle relaxed, unconscious, or heavily sedated)