Sucrose Practices for Pain in Neonates
- Conditions
- Pain
- Interventions
- Other: sucrose
- Registration Number
- NCT02134873
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 291
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.1ml 24% sucrose concurrent opioids sucrose 0.1ml 24% sucrose concurrent opioids 0.1ml 24% sucrose no opioids sucrose 0.1ml 24% sucrose no opioids 0.5ml 24% sucrose no opioids sucrose 0.5ml 24% sucrose no opioids 0.5ml 24% sucrose concurrent opioids sucrose 0.5ml 24% sucrose concurrent opioids 1.0ml 24% sucrose no opioids sucrose 1.0ml 24% sucrose no opioids 1.0ml 24% sucrose concurrent opioids sucrose 1.0ml 24% sucrose concurrent opioids
- Primary Outcome Measures
Name Time Method The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). Change from baseline 30 seconds post painful procedure Premature Infant Pain Profile- Revised is a validated pain measure to assess infant pain
- Secondary Outcome Measures
Name Time Method The secondary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). Change from baseline 60 seconds post painful procedure Premature Infant Pain Profile-Revised is a validated pain measure to assess infant pain
The secondary outcome is frequency of occurrence of adverse events. Starting from the administration of sucrose until the end of the procedure (procedure could last on average 6 minutes) or longer if indicated. The potential adverse events include: heart rate \>240 beats/minute or \<80 beats/minute for \>20 seconds, oxygen saturation \<80% for \> 20 seconds, no spontaneous respirations for \> 20 seconds, and choking or gagging.
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada