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The Use of Ketorolac in Surgical Neonates

Primary Purpose

Postoperative Pain Control in Surgical Neonates

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
placebo
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain Control in Surgical Neonates focused on measuring Ketorolac, postoperative pain, bleeding events

Eligibility Criteria

1 Week - 3 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ketorolac

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical parameters related to pain.
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.

Full Information

First Posted
August 15, 2012
Last Updated
May 2, 2023
Sponsor
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01667120
Brief Title
The Use of Ketorolac in Surgical Neonates
Official Title
The Use of Ketorolac in Surgical Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Control in Surgical Neonates
Keywords
Ketorolac, postoperative pain, bleeding events

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Postoperative surgical neonates will receive an equivalent volume of 0.9% normal saline as placebo.
Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
Postoperative ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac 0.5mg/kg IV q8h x 72h.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
0.9% normal saline
Intervention Description
0.9% normal saline 1ml/kg
Primary Outcome Measure Information:
Title
Safety from bleeding events.
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Clinical parameters related to pain.
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer H Aldrink, MD
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Use of Ketorolac in Surgical Neonates

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