Status:
COMPLETED
Assessment of Pain in Newborns and Older Infants (Infant Pain Assessment Study =
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Autonomous Healthcare, Inc.
Conditions:
Pain, Acute
Eligibility:
All Genders
1-6 years
Brief 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 frequen...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
- Newborns and infants requiring positive pressure ventilation using a face mask (BiPAP) or endotracheal tube (conventional or high-frequency ventilators).
- 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).
- Newborns and infants with facial anomalies, injuries or other pathologies affecting the facial area.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03330496
Start Date
October 30 2017
End Date
March 30 2022
Last Update
June 8 2022
Active Locations (1)
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1
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304