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Nonsteroidal Anti-inflammatory Drug

Ketorolac Dosing for Acute Pain in Children (KETODOSE Trial)

Phase 3

Recruiting

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 6.0 years to <18 years with currently experiencing moderate to severe pain

Be younger than 18 years old

Must not have

Recent use of ketorolac or opioids

Caregiver and/or child cognitive impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30, 90, 120 minutes and 6 hours post study drug administration

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial explores if a lower dose of a non-opioid medication (Ketorolac) can safely reduce pain in children 6-17 years old. It will also provide insight into how these medicines are perceived by families and kids.

Who is the study for?

This trial is for children aged 6 to less than 18 experiencing moderate to severe acute pain, who are in the emergency department or hospitalized with an IV line already in place. It's not for kids with chronic kidney or liver diseases, those who've taken ketorolac or opioids recently, have a history of bleeding disorders, known pregnancy, NSAID or opioid allergies, cognitive impairments that prevent consent, or are post-operative.

What is being tested?

The study tests three different doses of Ketorolac Tromethamine—a non-opioid painkiller—to find the smallest effective dose for children's pain relief without unnecessary side effects. Participants will be randomly assigned to receive one of two smaller doses or the normal dose used at MCH and will be monitored over two hours for pain levels and additional medication needs.

What are the potential side effects?

Ketorolac may cause side effects like gastrointestinal issues (stomach upset), bleeding problems especially if there's a history of ulcers or coagulation disorders. The goal is to minimize these risks by finding the lowest effective dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 18 years old and have moderate to severe pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have recently used ketorolac or opioids.

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Either I or my child has cognitive impairment.

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I have had surgery for my condition.

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I use painkillers every day for any reason.

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I have a history of bleeding disorders or specific gastrointestinal conditions.

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I have a long-term liver condition.

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I have a long-term kidney disease, not including kidney stones or UTIs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30, 90, 120 minutes and 6 hours post study drug administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30, 90, 120 minutes and 6 hours post study drug administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30, 90, 120 minutes and 6 hours post study drug administration for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change in category of pain

Opioid sparing

Pain relief

+3 more

Other study objectives

Safety outcome 1

Safety outcome 2

Survey to understand patients' and caregivers' knowledge, attitudes, perceptions, and emotions on pain, medications, and their use in treating acute pain.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Low dose group B2Experimental Treatment1 Intervention

IV ketorolac 0.25 mg/kg to a maximum of 30 mg plus IV normal saline placebo given at 0.5 mg/kg to a maximum of 30 mg plus IV normal saline placebo 0.5 mg/kg to a maximum of 10 mg

Group II: Low dose group B1Experimental Treatment1 Intervention

IV ketorolac 0.5 mg/kg to a maximum of 10 mg plus IV normal saline placebo given at 0.25 mg/kg to a maximum of 30 mg plus IV normal saline placebo given at 0.5 mg/kg to a maximum of 30 mg

Group III: Standard dose group AActive Control1 Intervention

IV ketorolac 0.5 mg/kg/dose up to a maximum dose of 30 mg plus IV normal saline placebo given at 0.25 mg/kg to a maximum of 30 mg plus IV normal saline placebo given at 0.5 mg/kg to a maximum of 10 mg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketorolac Tromethamine

2007

Completed Phase 4

~1450

0 / 8Eligibility criteria met