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The Use of Ketorolac in Surgical Neonates

This study is not yet open for participant recruitment.
Verified August 2012 by Nationwide Children's Hospital
Sponsor:
Collaborator:
The Research Institute at Nationwide Children's Hospital
Information provided by (Responsible Party):
Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01667120
First received: August 15, 2012
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Postoperative Pain Control in Surgical Neonates
 Drug: Ketorolac
Drug: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Safety from bleeding events. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Clinical parameters related to pain. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 106
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Postoperative surgical neonates will receive an equivalent volume of 0.9% normal saline as placebo.
 Drug: placebo
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.

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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667120

Locations
United States, Ohio
Nationwide Children's Hospital Not yet recruiting
Columbus, Ohio, United States, 43205
Contact: Jennifer H Aldrink, MD     614-722-0440     Jennifer.aldrink@nationwidechildrens.org    
Contact: Jonathan Wispe, MD         Jonathan.wispe@nationwidechildrens.org    
Principal Investigator: Jennifer H Aldrink, MD            
Sub-Investigator: Teresa Puthoff, PharmD            
Sub-Investigator: Jonathan Wispe, MD            
Sponsors and Collaborators
Nationwide Children's Hospital
The Research Institute at Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01667120     History of Changes
Other Study ID Numbers: 10-00554
Study First Received: August 15, 2012
Last Updated: August 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nationwide Children's Hospital:
Ketorolac
postoperative pain
bleeding events

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013