An observational study in Pain, Acute, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 1 Day to 6 Months. Per ClinicalTrials.gov, last updated 2022-06-08.
Sponsored by Stanford University · Observational
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.
We will collect data from 30 study subjects in each of the following age groups:
Exclusion Criteria:
preterm neonates (34-37 weeks gestational age, n=15)
Other: Pain Measurement
term newborns (37-42 weeks gestation, n=15)
Other: Pain Measurement
1-3 month-old infants (n=15)
Other: Pain Measurement
3-6 month-old infants (n=15)
Other: Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.
Pain Measurement (all infants)
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.
Time frame: 10 minutes
Pain Measurement
Facial Expressions specific for infant pain will be assessed, including nasolabial furrow and brow bulge. Presence or absence as well as the duration for each facial expression will be recorded during the painful procedure. These facial expressions were chosen from the Neonatal Facial Coding Scale (NFCS) and the Premature Infant Pain Profile (PIPP).
Time frame: 30 minutes
Pain Measurement (newborns 0-30 days)
Neonatal Pain, Agitation and Sedation Scale (N-PASS) measures level of sedation versus increasing pain or agitation in newborns. Scores range from -10 to +10, where negative scores denote increasing levels of sedation, zero indicates a neutral condition, and positive scores indicate increasing pain intensity and/or agitation.
Time frame: 5 minutes
Pain Measurement (newborns 0-30 days)
Premature Infant Pain Profile - Revised (PIPP-R) measures pain intensity in newborns, with scores ranging from 0 to 21, higher scores indicating greater pain (adjusted for prematurity and behavioral state).
Time frame: 8 minutes
Pain Measurement (infants 1-6 months)
Face, Legs, Activity, Cry, Consolability scale (FLACC scale) measures pain in children between the ages of 2 months and 7 years. The scale is scored in a range of 0-10 with 0 representing no pain and 10 indicating severe pain.
Time frame: 3 minutes
Plan to share: No — No data will be shared
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stanford University