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Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery

Study acronym: CIVIK
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 4 months later Jun 1, 2026 → Oct 1, 2027
See other at-risk trials from Phoenix Children's Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Primary completion pushed from Jun 1, 2026 to Oct 1, 2027
    • Study completion pushed from Dec 1, 2026 to Dec 1, 2027
    v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Minor Study Identification, Study Statusv6
  5. Notable Primary completion date: Jan 1, 2025 to Jun 1, 2026
    • Study completion date: Dec 1, 2025 to Dec 1, 2026
    • Site contact updated
    • Eligibility criteria expanded, about 1 word
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description revised
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Dec 2020 to Jan 1, 2025
    • Start date changed from estimate of Sep 2019 to Mar 1, 2021
    • Study completion date: Dec 2021 to Dec 1, 2025
    • Site details revised
  3. Minor Secondary endpoints: details revised at 1 of 5 entriesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular ICU. We intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.
Trial Details
NCT Number NCT04040452
Lead Sponsor Phoenix Children's Hospital
Conditions
(from sponsor)
Congenital Heart Disease in Children
Related terms Agnosia, Heart Defects, Congenital
Enrollment 166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov