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Postoperative Pain Control & Relief in Neonates (POPCORN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03677830
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : April 23, 2019
Information provided by (Responsible Party):
Gustavo Villalona MD, FACS, FAAP, St. Louis University

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Premature Infant Opioid Use Drug: Acetaminophen Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Acetaminophen
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.
Drug: Saline
Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. Apnea of >20 seconds [ Time Frame: 72 hours following surgical procedure ]
    Apnea episodes of >20 seconds documented by nursing staff after surgical procedure

  2. Time to first feed [ Time Frame: up to 2 weeks ]
    Number of hours to first enteral feeding after surgical procedure

  3. Time to full enteral feeds [ Time Frame: up to 8 weeks ]
    Number of hours/days until receiving all nutritional support enterally following surgical procedure

  4. Time to endotracheal extubation [ Time Frame: up to 2 weeks ]
    Number of hours from surgical procedure to endotracheal extubation

  5. Incidence of opiate withdrawal symptoms [ Time Frame: up to 8 weeks ]
    Number of infants that develop withdrawal symptoms from opiate exposure

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03677830

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Contact: Marya Strand, MD, MS 3145775642
Contact: Gustavo Villalona, MD 3145775629

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United States, Missouri
Cardinal Glennon Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63104
Contact: JoAnn Filla-Taylor, BSN, RN    314-977-7525   
Sponsors and Collaborators
St. Louis University

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Responsible Party: Gustavo Villalona MD, FACS, FAAP, Assistant Professor of Surgery-Pediatric Surgery, St. Louis University Identifier: NCT03677830     History of Changes
Other Study ID Numbers: 29544
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs