Acute PainPhase 3KETODOSENCT05641363
Comparison of Ketorolac at Three Doses in Children With Acute Pain
A Phase 3 study testing Ketorolac Tromethamine in people with Acute Pain and Abdominal Pain, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
Hospital Scene #1: A 6-year-old arrives in the Emergency Department at McMaster Children's Hospital (MCH) complaining of pain in his lower right side. His Dad explains the pain has been going on for a few hours and that Advil and Tyelnol haven't helped at all. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Acute Pain, Abdominal Pain, Migraine
- What is being tested?
- Ketorolac Tromethamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2023to 6 May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6.0 years to <18 years: primary outcome measure, 11-point vNRS is validated for use in children ≥6 years, and no other evidence-based acute pain measure is recommended for use in younger children Currently experiencing moderate to severe pain (self-reported pain score >4 using the vNRS at the time of enrollment; ketorolac is used to treat moderate to severe pain)
- Patients seen in the ED or inpatient setting with acute pain ≤30 days in duration
- Patient with IV cannula in situ or ordered (to minimize any additional pain or distress)
Who cannot join
- Previous enrollment in trial (to ensure all observations are independent and not paired)
- Post-operative patient (as this included medically induced pain, versus pathology-only)
- Ketorolac 6 hours and/or opioids 4 hours prior to recruitment (avoid over-dosing and confounding)
- Use of daily analgesic for any indications (confounding as response to analgesics maybe altered)
- Caregiver and/or child cognitive impairment (precludes the ability to respond to study questions)
- History of gastrointestinal bleed or ulcers, inflammatory bowel disease, coagulation disorders, cerebrovascular bleeding, known arterio-vascular malformations (increased bleeding risk)
Show all 11Show fewer
- History of chronic and active renal disease, excluding renal calculi and urinary tract infections
- History of chronic and active hepatocellular disease (ketorolac is metabolized in the liver)
- Known pregnancy at the time of enrollment (risk of closure of patent ductus arteriosus in fetus)
- Known hypersensitivity to NSAIDs or opioids
- Inability to obtain consent (language barrier and the absence of language translator)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
McMaster Children's Hospital
Hamilton, Ontario, L9H6k6
About this study
Official title: Comparison of Ketorolac at Three Doses in Children With Acute Pain: A Randomized Controlled Trial
Hospital Scene #1: A 6-year-old arrives in the Emergency Department at McMaster Children's Hospital (MCH) complaining of pain in his lower right side. His Dad explains the pain has been going on for a few hours and that Advil and Tyelnol haven't helped at all. He's anxious and concerned about his son because he never complains about pain - so this must be bad. After he has been seen by the doctor, the appendix appears to be the problem and the boy needs to have it removed. Dad wants his son's pain to go away but is worried because he once got a high dose of a medication and had some unwanted side effects.
Hospital Scene #2: A 14-year-old girl has been experiencing migraine headaches for the past months and is awaiting an appointment with a specialist. Today, however, the pain is the worst it's been. Mom has picked her up from school and brought her to MCH not knowing what else to do to help her. The Advil and Tylenol have not improved her pain. She desperately wants the pain to go away but is worried because she read that some pain medicines are used without any studies done to see if they work and if they are safe. (https://www.ottawalife.com/article/most-medications-prescribed-to-children-have-not-been-adequately-studied?c=9).
Read more
In both cases, these children need medicine to help their pain. The treating doctors want to give them pain medicine that will 1) be safe and 2) make the pain go away. This is what parents and the child/teenager, and the doctors want too. Some pain medicines like opioids are often used to help with pain in children. Unfortunately, opioids can have bad side effects and can, when used incorrectly or for a long time, be addictive and even dangerous. A better option would be a non-opioid, like Ketorolac, which also helps pain but is safer and has fewer side effects. The information doctors have about how much Ketorolac to give a child, though, is what has been learned from research in adults. Like with any medication, the smallest amount that a child can take while still getting pain relief is best and safest. Why give more medicine and have a higher risk of getting a side effect, if a lower dose will do the trick? This is what the researchers don't know about Ketorolac and what this study aims to find out.
Children 6-17 years old who are reporting bad pain when they are in the Emergency Department or admitted in hospital and who will be getting an intravenous line in their arm will be included in the study. Those who want to participate will understand that the goal of the study is to find out if a smaller amount of medicine improves pain as much as a larger amount. By random chance, like flipping a coin, the child will be placed into a treatment group. The difference between these treatment groups is the amount of Ketorolac they will get. One treatment will be the normal dose that doctors use at MCH, and the other two doses will be smaller. Neither the patient, parent nor doctor will know how much Ketorolac they are getting. Over two hours, the research nurse or assistant will ask the child how much pain they are in. Our research team will also measure how much time it took for the pain to get better, and whether the child had to take any other medicine to help with pain. The research team will also ask families and patients some questions to understand their perceptions of pain control, pain medicines and side effects they know of.
This research is important because it may change the way that doctors treat children with pain, not just at MCH but around the world. The results of this study will be shared with doctors through conferences and scientific papers. It's also important that clinicians share information with parents and children so that they can understand more about pain medicines and how these medicines can be used safely with the lowest chance of side effects.
Read the detailed description
Comparison of Ketorolac at Three Doses In Children With Acute Pain: A Randomized Controlled Trial (KETODOSE TRIAL)
Background: Despite the ongoing opioid crisis, opioids remain a commonly prescribed analgesic for patients with acute pain. Ketorolac is the leading parenteral non-steroidal anti-inflammatory drug (NSAID) in Canada commonly used in the Emergency Department (ED) and inpatient settings for acute abdominal pain and migraine headaches. Though it has safer adverse event profile than opioids, its use in children is off label as there are virtually no pediatric trials to inform this practice. Currently the recommended dosing for children is 0.5 mg/kg to a maximum dose of 30 mg. Recent trials with adults have shown no added analgesic benefit to higher doses of ketorolac, when comparing 10 mg to 15 mg or 30 mg, intravenous (IV). A lower dose will be desirable if it achieves similar reduction of pain, as it allows for safer cumulative daily dosing and lower rates of adverse events. This has led many physicians to change their adult practice to a maximum dose of 10 mg IV; however, despite their smaller size, most children continue to be exposed to doses of 30 mg IV, due to a lack of similar available evidence.
Research Question: In children aged 6 - 17 years, with moderate to severe pain (measured using the 11-point verbal numerical rating scale (VNRS)), who are prescribed IV Ketorolac by their treating physician, is low-dose IV Ketorolac (0.25 mg/kg/dose up to 10 mg OR 0.5 mg/kg/dose up to 10 mg) non-inferior (NI) to standard treatment (0.5 mg/kg/dose up to 30 mg) in reducing mean pain scores within a NI margin of 1?
Study Design: Our trial is a single-center, block randomized, double-dummy, double-blind, three-arm, controlled trial with parallel groups. Participants will include: (i) ≥6 years; (ii) with moderate-severe pain (defined as VNRS > 4; (iii) seen in the ED or inpatient setting; and (iv) who have an IV access planned/available. These individuals will be randomized to an arm with active ketorolac and a 'placebo' ketorolac of a differing dose, to maintain blinding through the double-dummy design: (1) standard-dose ketorolac (0.5 mg/kg IV up to 30 mg IV) + low-dose ketorolac placebo; (2) low-dose ketorolac (0.25 mg/kg up IV up to 10 mg IV) + standard-dose ketorolac placebo; or (3) low-dose ketorolac (0.5 mg/kg IV up to 10 mg) + standard-dose ketorolac placebo.
Participants will be allowed any other non-NSAID rescue therapy at any point after our trial drugs are administered, based on clinical team discretion. Based on available adult literature, a chosen NI margin of 1 point (50% of the established MID), an expected mean difference of 0.2 on the VNRS, and standard deviation of 1.5 points, 57 participants will be needed in each group to achieve a 5% alpha at 80% power.
Primary Outcomes: Between each low-dose ketorolac group and standard group mean differences in pain as measured on VNRS at 60 minutes.
Summary: Acute pain requiring parenteral analgesia is very common amongst Canadian children.Despite data in adults and children supporting preferential NSAID use for acute pain, significant gaps in knowledge regarding safe and effective Ketorolac dosing in children still exists. The drug's superior adverse effect profile and lack of dependence and abuse potential, makes this an appropriate than opioids, and is not known to be a substance of misuse.
- Conditions
- Acute Pain, Abdominal Pain, Migraine, Appendicitis Acute, Renal Colic, Biliary Colic
- Being tested
- Ketorolac Tromethamine
- Medical subject headings
- Acute Pain, Abdominal Pain, Migraine Disorders, Appendicitis, Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called ketorolac, toradol, intravenous ketorolac
ketorolac tromethamine, an NSAID belonging to a group of non-opioid analgesics that inhibit the synthesis of prostaglandins and thromboxanes with strong analgesic and anti-inflammatory properties. It is the only non-opioid parenteral non-sedating analgesic available for use to treat acute pain in the emergency department.
| Study group | Role | What they receive |
|---|---|---|
| Standard dose group A | Active comparator | 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 Receives: Drug: Ketorolac Tromethamine |
| Low dose group B1 | Experimental | 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 Receives: Drug: Ketorolac Tromethamine |
| Low dose group B2 | Experimental | 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 Receives: Drug: Ketorolac Tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Between each low-dose ketorolac group (B1 and B2) and standard group (A) mean differences in pain as measured on an 11-point verbal Numerical Rating Scale (0 is no pain and 10 is worst pain ever)
Measured: 60 minutes post drug administration
Secondary outcomes (6)
Pain relief
11-point verbal Numerical Rating Scale (0 is no pain and 10 is worst pain ever) score at 30, 90 and 120 minutes as well as 6 to 8 hours post administration.
Measured: 8 hours post study drug administration
Pain relief by a minimally important difference (MID)
Proportion of participants who achieves the 2-point reduction in the 11-point verbal numerical rating scale MID pain score reduction.
Measured: 60 and 120 minutes post study drug administration
Change in category of pain
Proportion of participants who change the severity of their baseline pain category at all time points (mild = 0 to 3, moderate = 4 to 6, severe ≥7 on the verbal numerical rating scale)
Measured: 30, 90, 120 minutes and 6 hours post study drug administration
Time to effective analgesia
time at which a verbal numerical rating scale <3 is achieved post-intervention
Measured: Within 8 hours post study drug administration
Rescue analgesia use
Proportion of participants requiring rescue analgesia in each trial arm
Measured: Within 8 hours post study drug administration
Opioid sparing
The total amount of opioids administered as measured by morphine equivalent mg/kg
Measured: Within 8 hours post study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Jun 2023
- Primary completion24 Apr 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Mohamed Eltorki, MBChB, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641363
- Sponsor's protocol ID
- KETODOSE20221107
- Acronym
- KETODOSE
- Status last verified
- Sep 2023
- First submitted
- 7 Nov 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data can be shared to individual researchers with reasonable request made to the primary investigator and within what is permitted by Hamilton integrated Review Ethics Board.
Publications
Eltorki M, Carciumaru R, Ali S, Holbrook A, Livingston M, Samiee-Zafarghandy S, Beattie K, Thabane L, Giglia L. Comparison of Ketorolac at 3 Doses in Children With Acute Pain: Protocol for A Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 26;14:e76554. doi: 10.2196/76554.
PubMed 41066173
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ketorolac at Three Doses in Children With Acute Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05641363
- Acronym / sponsor ID
- KETODOSE / KETODOSE20221107
- Conditions
- Acute Pain, Abdominal Pain, Migraine, Appendicitis Acute, Renal Colic, Biliary Colic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hospital Scene #1: A 6-year-old arrives in the Emergency Department at McMaster Children's Hospital (MCH) complaining of pain in his lower right side. His Dad explains the pain has been going on for a few hours and that Advil and Tyelnol haven't helped at all. He's anxious and concerned about his son because he never complains about pain - so this must be bad. After he has been seen by the doctor, the appendix appears to be the problem and the boy needs to have it removed. Dad wants his son's pain to go away but is worried because he once got a high dose of a medication and had some unwanted side effects.
Hospital Scene #2: A 14-year-old girl has been experiencing migraine headaches for the past months and is awaiting an appointment with a specialist. Today, however, the pain is the worst it's been. Mom has picked her up from school and brought her to MCH not knowing what else to do to help her. The Advil and Tylenol have not improved her pain. She desperately wants the pain to go away but is worried because she read that some pain medicines are used without any studies done to see if they work and if they are safe. (https://www.ottawalife.com/article/most-medications-prescribed-to-children-have-not-been-adequately-studied?c=9).
In both cases, these children need medicine to help their pain. The treating doctors want to give them pain medicine that will 1) be safe and 2) make the pain go away. This is what parents and the child/teenager, and the doctors want too. Some pain medicines like opioids are often used to help with pain in children. Unfortunately, opioids can have bad side effects and can, when used incorrectly or for a long time, be addictive and even dangerous. A better option would be a non-opioid, like Ketorolac, which also helps pain but is safer and has fewer side effects. The information doctors have about how much Ketorolac to give a child, though, is what has been learned from research in adults. Like with any medication, the smallest amount that a child can take while still getting pain relief is best and safest. Why give more medicine and have a higher risk of getting a side effect, if a lower dose will do the trick? This is what the researchers don't know about Ketorolac and what this study aims to find out.
Children 6-17 years old who are reporting bad pain when they are in the Emergency Department or admitted in hospital and who will be getting an intravenous line in their arm will be included in the study. Those who want to participate will understand that the goal of the study is to find out if a smaller amount of medicine improves pain as much as a larger amount. By random chance, like flipping a coin, the child will be placed into a treatment group. The difference between these treatment groups is the amount of Ketorolac they will get. One treatment will be the normal dose that doctors use at MCH, and the other two doses will be smaller. Neither the patient, parent nor doctor will know how much Ketorolac they are getting. Over two hours, the research nurse or assistant will ask the child how much pain they are in. Our research team will also measure how much time it took for the pain to get better, and whether the child had to take any other medicine to help with pain. The research team will also ask families and patients some questions to understand their perceptions of pain control, pain medicines and side effects they know of.
This research is important because it may change the way that doctors treat children with pain, not just at MCH but around the world. The results of this study will be shared with doctors through conferences and scientific papers. It's also important that clinicians share information with parents and children so that they can understand more about pain medicines and how these medicines can be used safely with the lowest chance of side effects.
Detailed description
Comparison of Ketorolac at Three Doses In Children With Acute Pain: A Randomized Controlled Trial (KETODOSE TRIAL)
Background: Despite the ongoing opioid crisis, opioids remain a commonly prescribed analgesic for patients with acute pain. Ketorolac is the leading parenteral non-steroidal anti-inflammatory drug (NSAID) in Canada commonly used in the Emergency Department (ED) and inpatient settings for acute abdominal pain and migraine headaches. Though it has safer adverse event profile than opioids, its use in children is off label as there are virtually no pediatric trials to inform this practice. Currently the recommended dosing for children is 0.5 mg/kg to a maximum dose of 30 mg. Recent trials with adults have shown no added analgesic benefit to higher doses of ketorolac, when comparing 10 mg to 15 mg or 30 mg, intravenous (IV). A lower dose will be desirable if it achieves similar reduction of pain, as it allows for safer cumulative daily dosing and lower rates of adverse events. This has led many physicians to change their adult practice to a maximum dose of 10 mg IV; however, despite their smaller size, most children continue to be exposed to doses of 30 mg IV, due to a lack of similar available evidence.
Research Question: In children aged 6 - 17 years, with moderate to severe pain (measured using the 11-point verbal numerical rating scale (VNRS)), who are prescribed IV Ketorolac by their treating physician, is low-dose IV Ketorolac (0.25 mg/kg/dose up to 10 mg OR 0.5 mg/kg/dose up to 10 mg) non-inferior (NI) to standard treatment (0.5 mg/kg/dose up to 30 mg) in reducing mean pain scores within a NI margin of 1?
Study Design: Our trial is a single-center, block randomized, double-dummy, double-blind, three-arm, controlled trial with parallel groups. Participants will include: (i) ≥6 years; (ii) with moderate-severe pain (defined as VNRS > 4; (iii) seen in the ED or inpatient setting; and (iv) who have an IV access planned/available. These individuals will be randomized to an arm with active ketorolac and a 'placebo' ketorolac of a differing dose, to maintain blinding through the double-dummy design: (1) standard-dose ketorolac (0.5 mg/kg IV up to 30 mg IV) + low-dose ketorolac placebo; (2) low-dose ketorolac (0.25 mg/kg up IV up to 10 mg IV) + standard-dose ketorolac placebo; or (3) low-dose ketorolac (0.5 mg/kg IV up to 10 mg) + standard-dose ketorolac placebo.
Participants will be allowed any other non-NSAID rescue therapy at any point after our trial drugs are administered, based on clinical team discretion. Based on available adult literature, a chosen NI margin of 1 point (50% of the established MID), an expected mean difference of 0.2 on the VNRS, and standard deviation of 1.5 points, 57 participants will be needed in each group to achieve a 5% alpha at 80% power.
Primary Outcomes: Between each low-dose ketorolac group and standard group mean differences in pain as measured on VNRS at 60 minutes.
Summary: Acute pain requiring parenteral analgesia is very common amongst Canadian children.Despite data in adults and children supporting preferential NSAID use for acute pain, significant gaps in knowledge regarding safe and effective Ketorolac dosing in children still exists. The drug's superior adverse effect profile and lack of dependence and abuse potential, makes this an appropriate than opioids, and is not known to be a substance of misuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard dose group A | Active comparator | Drug: Ketorolac TromethamineIV 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 |
| Low dose group B1 | Experimental | Drug: Ketorolac TromethamineIV 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 |
| Low dose group B2 | Experimental | Drug: Ketorolac TromethamineIV 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 |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6.0 years to <18 years: primary outcome measure, 11-point vNRS is validated for use in children ≥6 years, and no other evidence-based acute pain measure is recommended for use in younger children Currently experiencing moderate to severe pain (self-reported pain score >4 using the vNRS at the time of enrollment; ketorolac is used to treat moderate to severe pain)
- Patients seen in the ED or inpatient setting with acute pain ≤30 days in duration
- Patient with IV cannula in situ or ordered (to minimize any additional pain or distress)
Key exclusion criteria (11 listed)
- Previous enrollment in trial (to ensure all observations are independent and not paired)
- Post-operative patient (as this included medically induced pain, versus pathology-only)
- Ketorolac 6 hours and/or opioids 4 hours prior to recruitment (avoid over-dosing and confounding)
- Use of daily analgesic for any indications (confounding as response to analgesics maybe altered)
- Caregiver and/or child cognitive impairment (precludes the ability to respond to study questions)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac TromethamineAlso: ketorolac, toradol, intravenous ketorolacketorolac tromethamine, an NSAID belonging to a group of non-opioid analgesics that inhibit the synthesis of prostaglandins and thromboxanes with strong analgesic and anti-inflammatory properties. It is the only non-opioid parenteral non-sedating analgesic available for use to treat acute pain in the emergency department. | Drug | Low dose group B1, Low dose group B2, Standard dose group A |
Primary outcome
Pain relief
Time frame: 60 minutes post drug administration
Between each low-dose ketorolac group (B1 and B2) and standard group (A) mean differences in pain as measured on an 11-point verbal Numerical Rating Scale (0 is no pain and 10 is worst pain ever)
6 secondary outcomes
Pain relief
Time frame: 8 hours post study drug administration
Pain relief by a minimally important difference (MID)
Time frame: 60 and 120 minutes post study drug administration
Change in category of pain
Time frame: 30, 90, 120 minutes and 6 hours post study drug administration
Time to effective analgesia
Time frame: Within 8 hours post study drug administration
Rescue analgesia use
Time frame: Within 8 hours post study drug administration
Opioid sparing
Time frame: Within 8 hours post study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 41066173Eltorki M, Carciumaru R, Ali S, Holbrook A, Livingston M, Samiee-Zafarghandy S, Beattie K, Thabane L, Giglia L. Comparison of Ketorolac at 3 Doses in Children With Acute Pain: Protocol for A Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 26;14:e76554. doi: 10.2196/76554.
- Individual participant dataSharing planned: Yes. Individual participant data can be shared to individual researchers with reasonable request made to the primary investigator and within what is permitted by Hamilton integrated Review Ethics Board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac Tromethamine in people with Acute Pain and Abdominal Pain, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 60 minutes post drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.