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Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 3 Months to 59 Months

Comparing continuous and intermittent ketorolac for pain control in children after heart surgery

Official title: Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients

Run by Phoenix Children's Hospital · NCT04040452 · Data updated 2026-11-12

This study is testing if giving children a steady drip of ketorolac for pain after heart surgery works better than giving it in doses, to see if it helps reduce the need for stronger pain medications.

Quick facts

PhasePhase 4
Study typeInterventional
Ages3 Months to 59 Months
SexAll
Enrollment166 (estimated)
SponsorPhoenix Children's Hospital
Academic / other
Locations1 site (Phoenix, Arizona)
StatusRecruiting
StartedMarch 1, 2021
Main results expectedOctober 1, 2027
Study endsDecember 1, 2027
Registry record updatedAugust 12, 2026
Trial IDNCT04040452 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 3 months to 4 years who are post-operative patients in the CVICU and are eligible for ketorolac for pain management.

Probably not a fit

Patients with acute kidney injury, significant bleeding, or those requiring mechanical circulatory support will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a prospective, randomized, double-blind, placebo-controlled trial aimed at evaluating the effectiveness of continuous versus intermittent ketorolac for postoperative pain management in pediatric patients undergoing cardiovascular surgery. The goal is to determine if continuous infusion of ketorolac can reduce the need for opioid medications compared to the standard intermittent dosing. Given the risks associated with opioid use in children, this research seeks to provide a safer alternative for pain control in the pediatric cardiovascular intensive care unit (CVICU). The study will involve patients aged 3 months to 4 years who are admitted postoperatively and will assess pain management outcomes within the first 72 hours after surgery.

Why it matters

Potential benefit: If successful, this study could lead to reduced opioid use in pediatric patients, minimizing the risk of complications associated with opioid therapy.

How similar studies have gone: There is existing evidence in adult literature supporting the use of continuous ketorolac for pain control, but this specific approach in pediatric patients is novel and untested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. All patients aged 3 months to 4 years 11months admitted post operatively to the CVICU during the time period in which the study will be ongoing
2. Initiation of study medication within the first 12-24 hours post-operatively
3. The cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive Ketorolac for pain control

Exclusion Criteria:

1. Patients that have acute kidney injury, as defined by the letter "I" in the pRIFLE criteria.
2. History of allergy or sensitivity reaction to ketorolac or any NSAID medications.
3. Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively
4. Orthotopic heart transplantation
5. Clinically significant bleeding
6. Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity

Where it's running

  • Phoenix Children's Hospital
    Phoenix, Arizona, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.