The Use of Ketorolac in Surgical Neonates

Nationwide Children's Hospital

Status and phase: Withdrawn; Phase 2

Conditions: Postoperative Pain Control in Surgical Neonates

Treatments: Drug: Ketorolac; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01667120

10-00554

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 week to 3 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Ketorolac

Experimental group

Description:

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

Treatment:

Drug: Ketorolac