The Use of Ketorolac in Surgical Neonates

NCT01667120 | Withdrawn Phase 2 DMC

• 1 other identifier: 10-00554
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain Control in Surgical Neonates

Keywords

Ketorolac; postoperative pain; bleeding events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical parameters related to pain.

  5 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Postoperative surgical neonates will receive an equivalent volume of 0.9% normal saline as placebo.

Drug: placebo

Ketorolac

EXPERIMENTAL

Postoperative ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered.

Drug: Ketorolac

Interventions

Ketorolac DRUG

Ketorolac 0.5mg/kg IV q8h x 72h.

Also known as: Toradol

Ketorolac

placebo DRUG

0.9% normal saline 1ml/kg

Also known as: 0.9% normal saline

Placebo

Eligibility Criteria

• Age: 1 Week - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Gestational age \< 37 weeks
• Age less than one week or greater than 3 months of age
• Known renal disease/dysplastic kidneys
• Serum Creatinine \> 0.4
• Patients who have rising creatinine levels the day prior to surgery (increase of at least 1.5-fold from baseline)
• 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 \[except for use in central venous catheter flushes\])
• Patients who undergo nephrectomy
• Patients with necrotizing enterocolitis
• Patients with a hemoglobin value \< 10g/dL
• Recent (within 3 months) GI bleeding, ulceration, and/or perforation
• Platelet count \< 50,000
• Ongoing disseminated intravascular coagulation or history of intraventricular hemorrhage
• Recent (within 2 weeks) use or current use of other nonsteroidal anti-inflammatory drugs (NSAIDS) besides aspirin (ASA)
• Allergy to ASA or other NSAIDS

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac; Ketorolac Tromethamine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jennifer H Aldrink, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 17, 2012
• Study Start: July 1, 2012
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)