What side effects are associated with this type of intervention?

Common treatments for Congenital Heart Disease (CHD) that involve anti-inflammatory and analgesic medications, such as Ketorolac, are associated with several side effects. These include gastrointestinal issues like ulcers and bleeding, cardiovascular risks such as increased risk of thrombotic events, and potential renal impairment. Other side effects may include increased blood pressure and fluid retention. It is important for patients to discuss these risks with their healthcare provider to ensure safe and effective management of their condition.

What prior FDA approvals exist?

FDA approvals for the treatment of Congenital Heart Disease (CHD) have primarily focused on addressing the structural and functional abnormalities of the heart. While Ketorolac is an anti-inflammatory and analgesic drug used for pain management, similar treatments for CHD include the use of medications like aspirin and clopidogrel, which are antiplatelet agents used to prevent thromboembolic events in patients with certain types of CHD. Additionally, sildenafil has been approved for managing pulmonary arterial hypertension in pediatric patients with CHD, providing symptomatic relief and improving exercise capacity. These treatments aim to manage symptoms and improve the quality of life for CHD patients.

What other types of research exist?

Promising novel alternatives to Ketorolac for Congenital Heart Disease patients include continuous infusion of non-opioid analgesics like acetaminophen and the use of selective COX-2 inhibitors such as celecoxib, which have shown efficacy in reducing inflammation and pain with a potentially better safety profile. Additionally, newer formulations of existing medications, such as intravenous ibuprofen, may offer effective pain management with reduced gastrointestinal side effects.

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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

Pivotal Trial

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Drug Has Already Been Approved

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 below

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My child is between 3 months and 4 years old and was admitted to the CVICU after surgery.

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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:

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I have had serious bleeding issues recently.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 72 hours after cardiac surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fentanyl

Secondary study objectives

Fentanyl

Major bleeding events

Pain scores

+2 more

Awards & Highlights

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.

Trial 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)

0 / 4Eligibility criteria met

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.