Sucrose Practices for Pain in Neonates (SPiN)

The Hospital for Sick Children

Status: Completed

Conditions: Pain

Treatments: Other: sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT02134873

1000038052

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 pain during invasive procedures and is a standard of care for painful procedures. The purpose of this study is to see what is the least amount of sucrose that can be given to a baby to reduce pain during procedures.

Full description

Infants in the NICU receive an average of 4 - 5 painful procedures daily for diagnostic and therapeutic purposes; less than half receive interventions to manage pain. Both immediate and long term effects of unmanaged pain in these vulnerable infants have been reported, including impaired brain development. To ensure optimal outcomes for hospitalized infants in NICUs, there is a crucial need to minimize procedural pain and its associated consequences. Multiple clinical trials have identified sucrose as an effective strategy for reducing procedural pain in infants. Despite its inclusion in neonatal pain guidelines, standards, and consensus statements sucrose has been inconsistently used. The under-utilization of sucrose may be explained by knowledge gaps in relation to the minimally effective dose and the influence of concurrent opioid analgesia, as well as the short and long-term effects of repeated administration. Once infants in the NICU are determined to be eligible for the study and parents consent, infants will be randomized to one of 3 dose of sucrose and their pain will be assessed using a validated pain assessment measure.

Enrollment: 291 patients

Sex: All

Ages: 1 day to 2 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants 24 to 42 weeks gestational age (GA) at birth, admitted to the Neonatal Intensive Care Unit (NICU), and scheduled to receive a heel lance will be eligible. Parents will be approached for participation within the first 2 weeks of the infant's life. Infants will be eligible for Trial 1, the non-opioid trial, if they have not received any opioids within 24 hours prior to the heel lance. Infants will be eligible for Trial 2, the opioid trial, if they are currently receiving an opioid infusion. Furthermore, observation of the procedures will be timed to ensure that no additional sucrose doses are provided within the previous 4 hours.

Exclusion criteria

• Infants will be excluded if they have a contraindication for sucrose administration (e.g., unable to swallow, pharmacologically muscle relaxed, or heavily sedated) due to safety concerns and/or inability to assess pain accurately (e.g., unable to clearly view the infant's face).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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291 participants in 6 patient groups

0.1ml 24% sucrose concurrent opioids

Active Comparator group

Description:

0.1ml 24% sucrose concurrent opioids

Treatment:

Other: sucrose

0.5ml 24% sucrose concurrent opioids

Active Comparator group

Description:

0.5ml 24% sucrose concurrent opioids

Treatment:

Other: sucrose

1.0ml 24% sucrose concurrent opioids

Active Comparator group

Description:

1.0ml 24% sucrose concurrent opioids

Treatment:

Other: sucrose

0.1ml 24% sucrose no opioids

Active Comparator group

Description:

0.1ml 24% sucrose no opioids

Treatment:

Other: sucrose

0.5ml 24% sucrose no opioids

Active Comparator group

Description:

0.5ml 24% sucrose no opioids

Treatment:

Other: sucrose

1.0ml 24% sucrose no opioids

Active Comparator group

Description:

1.0ml 24% sucrose no opioids

Treatment:

Other: sucrose