Back to resultsPostoperative Pain Control & Relief in Neonates (POPCORN)
Primary Purpose
Pain, Postoperative, Premature Infant, Opioid Use
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- Cardinal Glennon Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intravenous Acetaminophen
Intravenous Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
Total morphine exposure
Total amount of morphine received by infants for pain control post-operatively in mg/kg
Secondary Outcome Measures
Total "as needed" morphine exposure
Total "as needed" or prn doses of morphine received by infants for pain control post-operatively in mg/kg
Full Information
NCT ID
NCT03677830
First Posted
September 6, 2018
Last Updated
February 24, 2023
Sponsor
St. Louis University
1. Study Identification
Unique Protocol Identification Number
NCT03677830
Brief Title
Postoperative Pain Control & Relief in Neonates
Acronym
POPCORN
Official Title
Postoperative Pain Control & Relief in Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Premature Infant, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The intervention (intravenous acetaminophen) and placebo (saline) will be distributed by the pharmacy and are visually indistinguishable.
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Acetaminophen
Arm Type
Active Comparator
Arm 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.
Arm Title
Intravenous Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Ofirmev 10 MG/ML Injectable Solution
Intervention Description
Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.
Primary Outcome Measure Information:
Title
Total morphine exposure
Description
Total amount of morphine received by infants for pain control post-operatively in mg/kg
Time Frame
72 hours following surgical procedure
Secondary Outcome Measure Information:
Title
Total "as needed" morphine exposure
Description
Total "as needed" or prn doses of morphine received by infants for pain control post-operatively in mg/kg
Time Frame
72 hours following surgical procedure
Other Pre-specified Outcome Measures:
Title
Apnea of >20 seconds
Description
Apnea episodes of >20 seconds documented by nursing staff after surgical procedure
Time Frame
72 hours following surgical procedure
Title
Time to first feed
Description
Number of hours to first enteral feeding after surgical procedure
Time Frame
up to 2 weeks
Title
Time to full enteral feeds
Description
Number of hours/days until receiving all nutritional support enterally following surgical procedure
Time Frame
up to 8 weeks
Title
Time to endotracheal extubation
Description
Number of hours from surgical procedure to endotracheal extubation
Time Frame
up to 2 weeks
Title
Incidence of opiate withdrawal symptoms
Description
Number of infants that develop withdrawal symptoms from opiate exposure
Time Frame
up to 8 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Postoperative Pain Control & Relief in Neonates
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