Postoperative Pain Control & Relief in Neonates

NCT ID: NCT03677830

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-19
• Study Completion Date: 2024-03-07

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.

Conditions

Pain, Postoperative; Premature Infant; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.

Interventions

Acetaminophen

Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.

Intervention Type: DRUG

Saline

Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.

Intervention Type: DRUG

Other Intervention Names

Ofirmev 10 MG/ML Injectable Solution

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

• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Marya Strand, MD

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Countries

United States

Other Identifiers

29544

Identifier Type: -

Identifier Source: org_study_id