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Nonsteroidal Anti-inflammatory Drug

Ketorolac Dosing for Acute Pain in Children (KETODOSE Trial)

Q: To what extent could exposure to Group B1 at a low dose be hazardous?

Our Power Team scored the safety of Low dose group B1 as a 3 because this advanced clinical trial has evidence to suggest both efficacy and multiple layers of security.

Q: Is the minimum age requirement for this trial below 20 years old?

Eligible participants for this trial must be between 6 and 17 years of age. There are 82 clinical studies currently recruiting those under 18 and 222 targeting individuals over 65.

Q: Is it possible to enroll in this experiment at this time?

According to the details on clinicaltrials.gov, this medical trial is not currently open for enrollment. It was initially posted February 1st 2023 and its most recent update occurred November 29th 2022; however, there are 331 other investigations actively recruiting participants at this time.

Q: Is my eligibility sufficient to partake in this investigation?

This medical research is recruiting 171 patients aged between 6 and 17 years old who are experiencing acute <a href="https://www.withpower.com/clinical-trials/pain">pain</a>. To qualify, they must have a validated 11-point vNRS score of more than 4, be in the ED or an inpatient setting with their symptoms not exceeding 30 days, and have either had an IV cannula inserted or ordered.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

KETODOSE 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.Check my eligibility

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.See study design

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.

KETODOSE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

KETODOSE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in category of pain

Opioid sparing

Pain relief

+3 more

Other outcome measures

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.

KETODOSE 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,830 Total Patients Enrolled

1 Trials studying Acute Pain

24 Patients Enrolled for Acute Pain

McMaster UniversityOTHER

884 Previous Clinical Trials

2,598,145 Total Patients Enrolled

3 Trials studying Acute Pain

1,480 Patients Enrolled for Acute Pain

Media Library

Ketorolac Tromethamine (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05641363 — Phase 3

Acute Pain Research Study Groups: Standard dose group A, Low dose group B1, Low dose group B2

Acute Pain Clinical Trial 2023: Ketorolac Tromethamine Highlights & Side Effects. Trial Name: NCT05641363 — Phase 3

Ketorolac Tromethamine (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05641363 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent could exposure to Group B1 at a low dose be hazardous?

"Our Power Team scored the safety of Low dose group B1 as a 3 because this advanced clinical trial has evidence to suggest both efficacy and multiple layers of security."

Answered by AI

Is the minimum age requirement for this trial below 20 years old?

"Eligible participants for this trial must be between 6 and 17 years of age. There are 82 clinical studies currently recruiting those under 18 and 222 targeting individuals over 65."

Answered by AI

Is it possible to enroll in this experiment at this time?

"According to the details on clinicaltrials.gov, this medical trial is not currently open for enrollment. It was initially posted February 1st 2023 and its most recent update occurred November 29th 2022; however, there are 331 other investigations actively recruiting participants at this time."

Answered by AI

Is my eligibility sufficient to partake in this investigation?

"This medical research is recruiting 171 patients aged between 6 and 17 years old who are experiencing acute pain. To qualify, they must have a validated 11-point vNRS score of more than 4, be in the ED or an inpatient setting with their symptoms not exceeding 30 days, and have either had an IV cannula inserted or ordered."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Ketorolac at Three Doses in Children With Acute Pain

Mohamed Eltorki, MBChB 2023. "Comparison of Ketorolac at Three Doses in Children With Acute Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05641363.

All > Acute Pain