Postoperative Pain Control & Relief in Neonates (POPCORN)
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|ClinicalTrials.gov Identifier: NCT03677830|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative Premature Infant Opioid Use||Drug: Acetaminophen Drug: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The intervention (intravenous acetaminophen) and placebo (saline) will be distributed by the pharmacy and are visually indistinguishable.|
|Official Title:||Postoperative Pain Control & Relief in Neonates|
|Actual Study Start Date :||April 19, 2019|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||April 1, 2022|
Active Comparator: Intravenous Acetaminophen
Infants randomized to the intervention arm will receive scheduled IV acetaminophen per LexiComp dosing guideline (28 0/7-32 6/7 weeks 10 mg/kg/dose every 12 hours; 33 0/7-38 6/7 weeks 10 mg/kg/dose every 8 hours; >39 0/7 weeks 10 mg/kg/dose every 6 hours). N-PASS scores will guide administration of IV morphine. Continuous infusion of morphine will be started if an infant requires 3 doses of morphine within a 6-hour period and titrated as needed per N-PASS scores.
Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.
Other Name: Ofirmev 10 MG/ML Injectable Solution
Placebo Comparator: Intravenous Placebo
Infants randomized to the control arm will receive normal saline placebo IV at the appropriate volume and times for the gestational age. IV acetaminophen is concentrated at 10 mg/ml; corresponding saline volumes will be 1 ml to 5 ml, approximately, based on subject weight. Control infants will also have N-PASS scores assessed using the same protocol following the surgical procedure for 72 hours. Dosing of IV morphine will be the same as the dosing for the intervention arm.
Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.
- Total morphine exposure [ Time Frame: 72 hours following surgical procedure ]Total amount of morphine received by infants for pain control post-operatively in mg/kg
- Total "as needed" morphine exposure [ Time Frame: 72 hours following surgical procedure ]Total "as needed" or prn doses of morphine received by infants for pain control post-operatively in mg/kg
- Apnea of >20 seconds [ Time Frame: 72 hours following surgical procedure ]Apnea episodes of >20 seconds documented by nursing staff after surgical procedure
- Time to first feed [ Time Frame: up to 2 weeks ]Number of hours to first enteral feeding after surgical procedure
- Time to full enteral feeds [ Time Frame: up to 8 weeks ]Number of hours/days until receiving all nutritional support enterally following surgical procedure
- Time to endotracheal extubation [ Time Frame: up to 2 weeks ]Number of hours from surgical procedure to endotracheal extubation
- Incidence of opiate withdrawal symptoms [ Time Frame: up to 8 weeks ]Number of infants that develop withdrawal symptoms from opiate exposure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677830
|Contact: Marya Strand, MD, MSemail@example.com|
|Contact: Gustavo Villalona, MDfirstname.lastname@example.org|
|United States, Missouri|
|Cardinal Glennon Children's Hospital||Recruiting|
|Saint Louis, Missouri, United States, 63104|
|Contact: JoAnn Filla-Taylor, BSN, RN 314-977-7525 email@example.com|