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NCT03330496 · ClinicalTrials.gov registry record
Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 43
- Enrollment target
NCT03330496: Completed study, sponsored by Stanford University.
NCT03330496 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 43 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03330496 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 43 participants
- Enrollment target
Study Summary
Pain assessments in non-verbal, critically ill infants represent an important clinical challenge. Older children or adults can easily express their pain, but infants lack that capability. They frequently experience repetitive acute pain during routine ICU care, but their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant pain leads to immediate clinical instability and potentially long-term physical, behavioral, and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical complications and/or impaired brain growth. Bedside nurses currently assess pain using pain scores, before taking action to ameliorate pain. Pain scores increase nursing workload and provide subjective assessments, rather than objective data for evaluating infant pain. Consequently, infants exposed to skin-breaking procedures, surgery, or other painful conditions often receive variable and inconsistent pain management in the ICU. The investigators aim to develop a multimodal pain assessment system, using sensor fusion and novel machine learning algorithms to provide an objective measure of pain that is context-dependent and rater-independent. This will enhance the quality of pain management in ICUs and allow continuous pain monitoring in real-time.
Primary Outcome
Visual Analogue Scale (VAS) measures pain intensity based on observer assessment on a scale from 1 to 10, where higher values indicate more intense pain.
Interventions
- OTHER Pain Measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2017-10-30 |
| Est. Completion | 2022-03-30 |
What the finished NCT03330496 record still lists
NCT03330496 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Pain Measurement is the first listed.
NCT03330496 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03330496 about?
NCT03330496 is a clinical study titled "Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =". Pain assessments in non-verbal, critically ill infants represent an important clinical challenge. Older children or adults can easily express their pain, but infants lack that capability. They frequently experience repetitive acute pain during routine ICU care, but their analgesic management flounde...
What is the current status of trial NCT03330496?
This trial is currently completed. The enrollment target is 43 participants. The study started on 2017-10-30. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT03330496?
The interventions under investigation include: Pain Measurement (OTHER).
Who is sponsoring clinical trial NCT03330496?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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