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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1ml 24% sucrose concurrent opioids | Active Comparator | 0.1ml 24% sucrose concurrent opioids |
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| 0.5ml 24% sucrose concurrent opioids | Active Comparator | 0.5ml 24% sucrose concurrent opioids |
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| 1.0ml 24% sucrose concurrent opioids | Active Comparator | 1.0ml 24% sucrose concurrent opioids |
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| 0.1ml 24% sucrose no opioids | Active Comparator | 0.1ml 24% sucrose no opioids |
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| 0.5ml 24% sucrose no opioids | Active Comparator | 0.5ml 24% sucrose no opioids |
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| 1.0ml 24% sucrose no opioids | Active Comparator | 1.0ml 24% sucrose no opioids |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sucrose | Other | Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). | Premature Infant Pain Profile- Revised is a validated pain measure to assess infant pain | Change from baseline 30 seconds post painful procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome is pain intensity measured using the Premature Infant Pain Profile-Revised (PIPP-R). | Premature Infant Pain Profile-Revised is a validated pain measure to assess infant pain | Change from baseline 60 seconds post painful procedure |
| The secondary outcome is frequency of occurrence of adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonnie Stevens, RN, PhD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29475433 | Derived | Stevens B, Yamada J, Campbell-Yeo M, Gibbins S, Harrison D, Dionne K, Taddio A, McNair C, Willan A, Ballantyne M, Widger K, Sidani S, Estabrooks C, Synnes A, Squires J, Victor C, Riahi S. The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial. BMC Pediatr. 2018 Feb 23;18(1):85. doi: 10.1186/s12887-018-1026-x. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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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. |
| Starting from the administration of sucrose until the end of the procedure (procedure could last on average 6 minutes) or longer if indicated. |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000073893 |
| Sugars |