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

Pain, Acute Clinical Trial

— iPAS)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330496
• Other study ID #: IRB-39076
• Status: Completed
• Start date: October 30, 2017
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 30, 2022
• Est. primary completion date: April 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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 pregnancy.

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.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Other:
• Pain Measurement
Measurement of infant responses (behavioral and physiological) during a painful procedure.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital Stanford	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Autonomous Healthcare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Secondary	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).	30 minutes
Secondary	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.	5 minutes
Secondary	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).	8 minutes
Secondary	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.	3 minutes