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Involved investigators no longer at the investigating center
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Acetaminophen | Active Comparator | 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. |
|
| Intravenous Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine exposure | Total amount of morphine received by infants for pain control post-operatively in mg/kg | 72 hours following surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea of >20 seconds | Apnea episodes of >20 seconds documented by nursing staff after surgical procedure | 72 hours following surgical procedure |
| Time to first feed | Number of hours to first enteral feeding after surgical procedure |
Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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The intervention (intravenous acetaminophen) and placebo (saline) will be distributed by the pharmacy and are visually indistinguishable.
| Saline | Drug | Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo. |
|
| up to 2 weeks |
| Time to full enteral feeds | Number of hours/days until receiving all nutritional support enterally following surgical procedure | up to 8 weeks |
| Time to endotracheal extubation | Number of hours from surgical procedure to endotracheal extubation | up to 2 weeks |
| Incidence of opiate withdrawal symptoms | Number of infants that develop withdrawal symptoms from opiate exposure | up to 8 weeks |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |