Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =

Not Recruiting

Trial ID: NCT03330496


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.

Official Title

Using Machine-learning Algorithms to Assess Acute Pain in Nonverbal Infants

Stanford Investigator(s)


Inclusion Criteria:

   - 1. All infants less than 6 months of corrected chronological age. 2. Infants admitted
   to the participating ICUs at LPCH (NICU, PICU, CVICU). 3. Require an acute painful
   procedure for routine clinical care.

Exclusion Criteria:

   1. Newborns with birth trauma, intrapartum asphyxia (5-minute Apgar Score <4 or cord pH <
   7.01), fetal growth restriction (birth weight < 5th percentile for gestation),
   congenital anomalies or metabolic disorders, or any kind of brain injury.

   2. Newborns born to mothers with a history of heavy smoking or drug abuse (alcohol,
   cocaine, ketamine, heroin/other opiates) or psychiatric drugs used during this

   3. Newborns and infants requiring positive pressure ventilation using a face mask (BiPAP)
   or endotracheal tube (conventional or high-frequency ventilators).

   4. Newborns and infants receiving continuous infusions of opioid drugs (morphine,
   fentanyl, others) and nerve blocks or neuraxial analgesia affecting the site of the
   invasive procedure during the 24 hours prior to study entry. (Note: Infants receiving
   intermittent opioids or non-opioid analgesics (acetaminophen, ibuprofen, ketorolac,
   others) WILL NOT be excluded).

   5. Newborns and infants with facial anomalies, injuries or other pathologies affecting
   the facial area.


other: Pain Measurement

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305