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Acetaminophen for Postoperative Pain in Newborns (POPCORN Trial)
Phase 4
Waitlist Available
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Major procedures include laparoscopic or open Nissen fundoplication, duodenal atresia repair, Hirschsprung pull through, Ladd's procedure or excision of abdominal cyst, thoracoscopy or thoracotomy procedure, enterostomy or colostomy creation, exploratory laparotomy, revision or closure of enterostomy or colostomy, any Gastroschisis or omphalocele repair in operating room, repair or staged repair of congenital anorectal malformations, and resection of sacrococcygeal teratoma
All neonates ≥ 28 weeks of gestation and <44 weeks of gestation undergoing general surgery procedures and managed postoperatively in the Neonatal Intensive Care Unit (NICU)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours following surgical procedure
Awards & highlights
POPCORN Trial Summary
This trial will test whether adding acetaminophen to standard narcotic pain control reduces narcotic use and adverse effects in newborns.
Who is the study for?
This trial is for newborns aged ≥28 to <44 weeks undergoing certain surgeries and managed in the NICU. It's not for babies whose parents don't speak English, those with severe kidney issues, recent opiate use, drug withdrawal symptoms at birth, serious liver or brain hemorrhage conditions, or congenital diseases affecting pain assessment.Check my eligibility
What is being tested?
The study tests if adding acetaminophen (Tylenol©) to morphine can better manage postoperative pain in neonates than morphine alone. Babies will be randomly given either both drugs or just morphine after surgery and monitored for 72 hours.See study design
What are the potential side effects?
Morphine may cause breathing problems, longer need for a breathing tube, and withdrawal symptoms. Acetaminophen is generally safe but overuse can lead to liver damage; its safety as an addition to narcotic treatment in newborns is being studied.
POPCORN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had major surgery in my abdomen or chest.
Select...
My newborn is between 28 and 44 weeks old and needs surgery.
POPCORN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours following surgical procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours following surgical procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total morphine exposure
Secondary outcome measures
Total "as needed" morphine exposure
Other outcome measures
Apnea of >20 seconds
Incidence of opiate withdrawal symptoms
Time to endotracheal extubation
+2 morePOPCORN Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Intravenous AcetaminophenActive Control1 Intervention
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.
Group II: Intravenous PlaceboPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,644 Total Patients Enrolled
1 Trials studying Postoperative Pain
223 Patients Enrolled for Postoperative Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with hepatitis, not caused by TPN-related issues.I have had a severe brain bleed.I have a condition like myotonic dystrophy that affects how I feel or report pain.I have had minor surgeries like hernia repair or tube placements.I have had major surgery in my abdomen or chest.My baby was diagnosed with NAS or was exposed to opiates before birth.You have taken opiates within 14 days before the surgery.My creatinine level is above 2.0 mg/dl.My newborn is between 28 and 44 weeks old and needs surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Intravenous Acetaminophen
- Group 2: Intravenous Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What health concerns is Intravenous Acetaminophen utilized to treat?
"Catarrh is often treated using Intravenous Acetaminophen, a medication also used to ameliorate rhinorrhoea, musculoskeletal pain, and muscle spasms."
Answered by AI
Have any other investigations explored the use of Intravenous Acetaminophen?
"Currently, there are eighty-nine Intravenous Acetaminophen projects in progress with twenty-six of them at Stage 3. Pittsburgh, Pennsylvania contains a handful of these trials but overall, one thousand and three locations offer this medication to patients."
Answered by AI
What is the scope of enrolment for this medical experiment?
"Unfortunately, this trial has stopped recruiting patients and the last update to its page on clinicaltrials.gov was made on February 11th 2022. However, there are currently 626 studies searching for participants with pain disorders and 89 trials looking for those suffering from Intravenous Acetaminophen-related issues."
Answered by AI
Is there availability to join this research endeavor?
"Drawn from the clinicaltrials.gov website, it appears that this medical trial is not presently enrolling patients due to its last update occurring on February 11th 2022. Nonetheless, there are currently 715 other studies actively searching for participants."
Answered by AI
What risks exist with administering Intravenous Acetaminophen to patients?
"Intravenous Acetaminophen has been approved, thus our team at Power rated its safety a 3 on the scale of 1 to 3."
Answered by AI
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