The Use of Ketorolac in Surgical Neonates

NCT ID: NCT01667120

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2018-12-31

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.

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.

Conditions

Postoperative Pain Control in Surgical Neonates

Study Design

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

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

0.9% normal saline 1ml/kg

Ketorolac

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

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

Ketorolac 0.5mg/kg IV q8h x 72h.

Interventions

Ketorolac

Ketorolac 0.5mg/kg IV q8h x 72h.

Intervention Type: DRUG

placebo

0.9% normal saline 1ml/kg

Intervention Type: DRUG

Other Intervention Names

Toradol; 0.9% normal saline

Eligibility Criteria

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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer H Aldrink, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

10-00554

Identifier Type: -

Identifier Source: org_study_id