Postoperative Pain Control & Relief in Neonates

Pain, Postoperative Clinical Trial

— POPCORN  

Official title:

Postoperative Pain Control & Relief in Neonates

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03677830
• Other study ID #: 29544
• Status: Terminated
• Phase: Phase 4
• Start date: April 19, 2019
• Est. completion date: March 7, 2024

Study information

• Verified date: March 2024
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 7, 2024
• Est. primary completion date: March 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Premature Infant

Intervention

Drug:
• Acetaminophen
Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.
• Saline
Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.

Locations

Country	Name	City	State
United States	Cardinal Glennon Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apnea of >20 seconds	Apnea episodes of >20 seconds documented by nursing staff after surgical procedure	72 hours following surgical procedure
Other	Time to first feed	Number of hours to first enteral feeding after surgical procedure	up to 2 weeks
Other	Time to full enteral feeds	Number of hours/days until receiving all nutritional support enterally following surgical procedure	up to 8 weeks
Other	Time to endotracheal extubation	Number of hours from surgical procedure to endotracheal extubation	up to 2 weeks
Other	Incidence of opiate withdrawal symptoms	Number of infants that develop withdrawal symptoms from opiate exposure	up to 8 weeks
Primary	Total morphine exposure	Total amount of morphine received by infants for pain control post-operatively in mg/kg	72 hours following surgical procedure
Secondary	Total "as needed" morphine exposure	Total "as needed" or prn doses of morphine received by infants for pain control post-operatively in mg/kg	72 hours following surgical procedure