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Ketorolac for Postoperative Pain in Pediatric Heart Surgery
Phase 4
Recruiting
Led By Christopher A Thomas, PharmD
Research Sponsored by Phoenix Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients aged 3 months to 4 years admitted post operatively to the CVICU during the 12 month time period during which the study will be ongoing
Initiation of study medication within the first 48 hours post-operatively
Must not have
Clinically significant bleeding
Orthotopic heart transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 72 hours after cardiac surgery
Awards & highlights
Summary
This trial tests if giving ketorolac through an IV can reduce the need for opiates in children after heart surgery. The goal is to find a safer way to manage pain and reduce the risks associated with opiates. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) with potent pain-relieving effects and a relatively low incidence of adverse effects, often used to reduce opioid use and manage postoperative pain in various surgical settings.
Who is the study for?
This trial is for children aged 3 months to 4 years who have had heart surgery and are in the pediatric cardiovascular ICU. They must start the study medication within two days after surgery. Kids with NSAID allergies, recent heart transplants, significant bleeding, kidney injuries or needing intensive support like ECMO or CRRT can't participate.
What is being tested?
The study is testing if giving ketorolac continuously through an IV works better for pain control than giving it in separate doses (intermittently) after pediatric heart surgery. It's a controlled experiment where neither doctors nor patients know who gets which treatment to fairly compare outcomes.
What are the potential side effects?
Ketorolac may cause side effects such as stomach pain, nausea, vomiting, indigestion, headaches or drowsiness. In some cases, it might lead to more serious issues like ulcers or kidney problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 3 months and 4 years old and was admitted to the CVICU after surgery.
Select...
I started the study medication within 48 hours after surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had serious bleeding issues recently.
Select...
I have had a heart transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 72 hours after cardiac surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 72 hours after cardiac surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fentanyl
Secondary outcome measures
Fentanyl
Major bleeding events
Pain scores
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
1. Description: Patients randomized for the treatment arm of the study group will receive a continuous infusion of ketorolac plus an intermittent dose of placebo (plasmalyte). To eliminate excess exposure and the associated side effects, all patients enrolled in the study will not be given any additional NSAIDs (except aspirin, which is standard of care in many post-operative cardiac surgery patients) during the study period.
2. Dosage and Route of Administration:
1. Continuous ketorolac 0.08mg/kg/hr, with a maximum of 5mg/hr for patients weighing greater than or equal to 60kg, administered intravenously by nursing staff. Study drug will infuse continuously for 48 hours.
2. Intermittent Plasmalyte 0.033mL/kg (max 2mL) infusion every 6 hours for 48 hours.
Group II: Standard of carePlacebo Group1 Intervention
1. Description: Patients randomized to the standard of care arm of the study will receive a generically marked syringe of Plasmalyte to be infused at the same rate as the treatment medication, and will only receive intermittent dosing of ketorolac (current standard of care). As in the treatment group, no additional NSAIDs (except aspirin) are to be given during the 48 hour study period.
2. Dosage and Route of Administration
1. Continuous Plasmalyte infusion to match the aforementioned ketorolac dosing
2. Intermittent ketorolac 0.5mg/kg IV infusion every 6 hours (max 30mg per dose)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Congenital Heart Disease (CHD) include anti-inflammatory and analgesic medications like Ketorolac, which work by inhibiting the cyclooxygenase (COX) enzymes, thereby reducing the production of prostaglandins that cause pain and inflammation. This is crucial for CHD patients, especially post-surgery, as it helps manage pain and reduce the need for opiates, which have significant side effects.
Additionally, other treatments such as inotropes improve heart contractility, and vasodilators reduce vascular resistance, both of which are essential for optimizing cardiac function and perfusion in CHD patients.
Medical treatment of pulmonary hypertension in adults with congenital heart disease: updated and extended results from the International COMPERA-CHD Registry.Hemodynamic considerations in preterm infants born at less than 25 weeks gestation.Transcatheter Intervention for Congenital Defects Involving the Great Vessels: JACC Review Topic of the Week.
Medical treatment of pulmonary hypertension in adults with congenital heart disease: updated and extended results from the International COMPERA-CHD Registry.Hemodynamic considerations in preterm infants born at less than 25 weeks gestation.Transcatheter Intervention for Congenital Defects Involving the Great Vessels: JACC Review Topic of the Week.
Find a Location
Who is running the clinical trial?
Phoenix Children's HospitalLead Sponsor
74 Previous Clinical Trials
5,013,580 Total Patients Enrolled
Christopher A Thomas, PharmDPrincipal InvestigatorPharmacy Department
Kevin Engelhardt, MDPrincipal InvestigatorHeart Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had serious bleeding issues recently.I needed heart or kidney support machines right after surgery.You have had a bad reaction to ketorolac or other similar pain medications in the past.You have a condition called acute kidney injury, as defined by specific criteria.I have had a heart transplant.My child is between 3 months and 4 years old and was admitted to the CVICU after surgery.I started the study medication within 48 hours after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Standard of care
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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