Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Use of Ketorolac in Surgical Neonates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Nationwide Children's Hospital.
Recruitment status was  Not yet recruiting
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

August 15, 2012
August 16, 2012
July 2012
July 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01667120 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Use of Ketorolac in Surgical Neonates
Not Provided

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain Control in Surgical Neonates
  • Drug: Ketorolac
    Ketorolac 0.5mg/kg IV q8h x 72h.
  • Drug: placebo
  • Placebo Comparator: Placebo
    Postoperative surgical neonates will receive an equivalent volume of 0.9% normal saline as placebo.
    Intervention: Drug: placebo
  • Experimental: Ketorolac
    Postoperative ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered.
    Intervention: Drug: Ketorolac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
106
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
up to 3 Months
No
United States
 
NCT01667120
10-00554
Yes
Nationwide Children's Hospital
Nationwide Children's Hospital
The Research Institute at Nationwide Children's Hospital
Not Provided
Nationwide Children's Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP