Saint Louis, Missouri 63104


Purpose:

Pain control for newborns has made significant improvements over the last 30 years. The use of narcotics remains the standard of care for neonates undergoing minor and major surgeries. Narcotics, however, are associated with adverse effects such as respiratory depression, prolonged intubation and withdrawal symptoms. Acetaminophen (Tylenol©) has been proposed as an adjunct to reduce narcotic use but current evidence from well designed studies in newborns and premature infants is limited. This study will randomly assign neonates undergoing a surgery to either morphine plus acetaminophen or morphine alone for pain control. The subjects will be followed for 72 hours after the operation and evaluate the benefits of acetaminophen for pain control.


Criteria:

Inclusion Criteria: - All neonates ≥ 28 weeks of gestation and <44 weeks of gestation undergoing general surgery procedures (below) and managed postoperatively in the Neonatal Intensive Care Unit (NICU). Minor procedures Inguinal hernia repair Laparoscopic or open gastrostomy tube placement Peritoneal drain placement for spontaneous intestinal perforation Gastroschisis bedside patch closure Major procedures 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 Resection of sacrococcygeal teratoma Exclusion Criteria: - Any infant admitted with preoperative diagnosis of neonatal abstinence syndrome (NAS) or known intrauterine opiate exposure - Any diagnosis of hepatitis exclusive of TPN-related biliary cholestasis - Renal disease with creatinine >2.0 mg/dl at enrollment - Intraventricular hemorrhage grade 3 or greater, or cerebellar hemorrhage - Any patient with myotonic dystrophy or other congenital disease limiting validity of pain scoring - Opiate exposure within 14 days of operative procedure - Non-English-speaking parents/guardians


Study is Available At:


Original ID:

29544


NCT ID:

NCT03677830


Secondary ID:


Study Acronym:

POPCORN


Brief Title:

Postoperative Pain Control & Relief in Neonates


Official Title:

Postoperative Pain Control & Relief in Neonates


Overall Status:

Recruiting


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

1 Month


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

St. Louis University


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Marya Strand, MD, MS
3145775642
marya.strand@health.slu.edu
Backup Contact:Gustavo Villalona, MD
3145775629
gustavo.villalona@health.slu.edu

Study Dates

Start Date:April 19, 2019
Completion Date:April 1, 2022
Completion Type:Anticipated
Primary Completion Date:April 1, 2022
Primary Completion Type:Anticipated
Verification Date:April 2019
Last Changed Date:April 19, 2019
First Received Date:September 6, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Total morphine exposure
Time Frame:72 hours following surgical procedure
Safety Issues:False
Description:Total amount of morphine received by infants for pain control post-operatively in mg/kg
Outcome Type:Secondary Outcome
Measure:Total "as needed" morphine exposure
Time Frame:72 hours following surgical procedure
Safety Issues:False
Description:Total "as needed" or prn doses of morphine received by infants for pain control post-operatively in mg/kg

Study Interventions

Intervention Type:Drug
Name:Acetaminophen
Description:Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.
Arm Name:Intravenous Acetaminophen
Other Name:Ofirmev 10 MG/ML Injectable Solution
Intervention Type:Drug
Name:Saline
Description:Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.
Arm Name:Intravenous Placebo

Study Arms

Study Arm Type:Active Comparator
Arm Name:Intravenous Acetaminophen
Description: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.
Study Arm Type:Placebo Comparator
Arm Name:Intravenous Placebo
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Louis University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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