The Use of Ketorolac in Surgical Neonates

The general purpose of this study is to characterize the safety profile of ketorolac in infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9% normal saline as placebo.

Primary: The primary purpose of this study is to compare bleeding events in neonates who receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.

Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine output per shift, platelet counts, hemoglobin levels, number of days on the ventilator, amount of narcotic administered, blood pressure, and reintubation events on all patients in this study as secondary study points.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Control in Surgical Neonates
• Intervention / Treatment: Drug: Ketorolac; Drug: placebo

Detailed Description

This is a Phase II, single center, randomized controlled pilot study. Hospitalized patients one week of age to 3 months of age who undergo an abdominal surgical procedure within the moderate or severe degree of pain category (see attached Table 1: postoperative pain categories) will be randomized to receive standard pain management regimens plus placebo (0.9% saline of equivalent volume) or ketorolac 0.5mg IV q8h x 72h plus standard pain management regimens. The postoperative management will be unchanged and at the discretion of the attending surgeon, as appropriate for the surgical procedure. The patients will be followed for 5 days, or 48hrs from the end of ketorolac therapy for primary and secondary endpoints.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 3 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Infants gestational age > 37 weeks and greater than or equal to one week of age to 3 months of age
2. Infants who are undergoing a surgical procedure on the abdomen
3. the parent or guardian has given informed consent.

Exclusion Criteria:

1. Gestational age < 37 weeks
2. Age less than one week or greater than 3 months of age
3. Known renal disease/dysplastic kidneys
4. Serum Creatinine > 0.4
5. Patients who have rising creatinine levels the day prior to surgery (increase of at least 1.5-fold from baseline)
6. Patients who are currently receiving other potentially renal toxic drugs or drugs that may interfere with hemostatic pathways as part of their clinical care (including but not limited to furosemide, hydrochlorothiazide, vancomycin, gentamicin, aspirin, tpa [except for use of thrombosed central venous catheters], enalapril, systemic heparin [except for use in central venous catheter flushes])
7. Patients who undergo nephrectomy
8. Patients with necrotizing enterocolitis
9. Patients with a hemoglobin value < 10g/dL
10. Recent (within 3 months) GI bleeding, ulceration, and/or perforation
11. Platelet count < 50,000
12. Ongoing disseminated intravascular coagulation or history of intraventricular hemorrhage
13. Recent (within 2 weeks) use or current use of other nonsteroidal anti-inflammatory drugs (NSAIDS) besides aspirin (ASA)
14. Allergy to ASA or other NSAIDS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Postoperative surgical neonates will receive an equivalent volume of 0.9% normal saline as placebo.	Drug: placebo; 0.9% normal saline 1ml/kg; Other Names: 0.9% normal saline
Experimental: Ketorolac; Postoperative ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered.	Drug: Ketorolac; Ketorolac 0.5mg/kg IV q8h x 72h.; Other Names: Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety from bleeding events.	Primary: The primary purpose of this study is to compare bleeding events in neonates who receive ketorolac and those who do not receive ketorolac. We hypothesize that ketorolac is safe and effective in infants > 37wks gestation and at least one week of age.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical parameters related to pain.	We intend to evaluate daily creatinine levels, pain scores, urine output per shift, platelet counts, hemoglobin levels, number of days on the ventilator, amount of narcotic administered, blood pressure, and reintubation events on all patients in this study as secondary study points.	5 days

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Investigators: Principal Investigator: Jennifer H Aldrink, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 15, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: postoperative pain; Ketorolac; bleeding events
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: 10-00554