Acute PainPhase 3KETOAPPNCT06160778
Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain
A Phase 3 study testing Ketorolac Tromethamine, Morphine Sulfate and normal saline in people with Acute Pain and Abdomen, Acute, run by University of Calgary at 1 site in Canada.
Trial summary
Appendicitis is a common condition in children 6-17 years of age, and the top reason for emergency surgery in Canada. Children with appendicitis can have very bad pain in their belly. Children often need pain medications given to them through a needle in their arm called an intravenous (IV). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Acute Pain, Abdomen, Acute, Abdominal Pain
- What is being tested?
- Ketorolac Tromethamine, Morphine Sulfate and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteCanada
- Study dates
- 27 May 2024to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 17 years
- Abdominal pain ≤5 days duration
- Acute abdominal pain that is being investigated (suspected) by the clinical team for appendicitis
- Patient with IV cannula in situ or ordered
- Currently experiencing moderate to severe abdominal pain at rest or with movement: self-reported pain score ≥5 using the verbal Numerical Rating Scale
Who cannot join
- Previous enrollment in the trial
- NSAID use within 3 hours and/or opioid use within 1 to 2 hours (1 hour post-IV or intra-nasal fentanyl and 2 hours post IV morphine).
- Children who need immediate resuscitation, are hemodynamically unstable as deemed by the clinical team or have a Canadian Triage Assessment Score of 1
- Significant caregiver and/or child cognitive impairment precluding the ability to complete study questions.
- Chronic pain requiring daily analgesic use: confounding as response to analgesics maybe altered.
- History of severe undiagnosed gastrointestinal bleeding requiring medical intervention, peptic or duodenal ulcer disease or inflammatory bowel disease, coagulation disorders, prior cerebrovascular bleeding, known arterio-vascular malformations. History of minor gastrointestinal bleeding from conditions such as resolved fissures, polyps or allergic colitis will not exclude patients from participating.
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- History of chronic and active interstitial kidney disease
- History of chronic and active hepatocellular disease: ketorolac is metabolized by the liver.
- Known or suspected pregnancy at the time of enrollment or breastfeeding females
- Known hypersensitivity to NSAIDs or opioids.
- Absence of a parent/guardian for children who are <16 years of age if they are not a mature minor.
- Inability to obtain consent due to a language barrier and the absence of language translator in person or by a phone translation service available in the ED.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Alberta Children's Hospital Emergency Department
Calgary, Alberta, T3B 6A8
Angela Wallace, 403-955-5451, angela.wallace@ahs.ca
Mohamed Eltorki, MBChB, MSc, 403-905-7723, mmeltork@ucalgary.ca
About this study
Official title: Intravenous Ketorolac Vs. Morphine In Children Presenting With Acute Abdominal Pain And/or Suspected Appendicitis: A Multi-centre Non-Inferiority Randomized Controlled Trial
Appendicitis is a common condition in children 6-17 years of age, and the top reason for emergency surgery in Canada. Children with appendicitis can have very bad pain in their belly. Children often need pain medications given to them through a needle in their arm called an intravenous (IV). The most common IV pain medication is a type of opioid called morphine. We know that opioids work well to improve pain, but there are risks and side effects when taking them. There are non-opioid medications that doctors can give to patients, like ketorolac. Ketorolac helps decrease inflammation and pain and has fewer side effects when a patient takes it for a short period of time. Our past and present overuse of opioids, driven by an unproven assumption that opioids work best for pain, resulted in an Opioid Crisis and doctors are now looking for alternatives. To do this, we need to prove that there are other options to treat children's pain that are just as good as opioids, with less side effects.
The goal of our study is to discover if school aged children who arrive at the emergency department with belly pain, improve just as much with ketorolac as they do with morphine. To answer this question, we will need a very large number of patients in a study that includes several hospitals across Canada. With a flip of a coin, each participant will either get a single dose of morphine or a single dose of ketorolac. To make sure that our pain assessment is impartial, no one will know which medicine the child received except the pharmacist who prepared the medicine.
Read the detailed description
Background: Appendicitis, the most common surgical diagnosis in Canadian children aged 6-17 years, accounts for ~8000 admissions annually. Despite an ongoing opioid crisis, prescription narcotics remain a mainstay analgesic for children with suspected appendicitis. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), which has a safer adverse event (AE) profile than opioids, is commonly used in emergency departments (EDs) for adults; however, use in children is considered off label due to a lack of randomized trials in this patient population. We propose a multi-centre clinical trial to address this knowledge gap,informed by our team's successful pilot trial.
Specific Aim 1: To determine if administering intravenous (IV) ketorolac is non inferior to IV morphine in reducing mean pain scores in children with suspected appendicitis.
Hypothesis: IV ketorolac will be non-inferior to IV morphine
Specific Aim 2: To determine between group differences in rates of AEs. Hypothesis: IV ketorolac will be associated with less AEs than IV morphine.
Design: A randomized quadruple blind (participant, clinician, outcome assessor, investigator) parallel group double-dummy trial in 4 Canadian pediatric EDs. Eligible patients will be 6-17 years with 5-days of moderate-severe pain (vNRS ≥5 ) being investigated for suspected appendicitis, with intravenous (IV) access, will be randomized to either:
- IV ketorolac 0.5 mg/kg up to 30 mg (intervention) + IV morphine placebo (normal saline), or
- IV morphine 0.1 mg/kg up to 5 mg (active control) + IV ketorolac placebo (normal saline).
Primary outcome: Between-group mean difference in pain on the vNRS at 60 minutes following administration.
Safety outcome: Proportion of children experiencing AEs related to study drug administration.
Secondary Outcomes: Between-group differences: (1) pain relief as measured on vNRS at 30, 90 and 120 minutes and at 6-8 hours; (2) proportion who achieves a 2-point vNRS (minimal important difference) pain score reduction at 60 and 120 minutes; (3) proportion of patients who change their baseline pain category (vNRS: mild 0-3, moderate 4-6, severe ≥7) at each time point; (4) time to effective analgesia as measured by the time when vNRS of <3 is achieved (5) proportion of patients requiring additional analgesia; (6) total opioids administered (i.e., morphine equivalent mg/kg within 8 hours of treatment); (7) frequency of specific types of AEs (e.g., dizziness); (8) frequency of delayed appendicitis diagnosis; and (9) Ramsay Sedation Score at 30, 60, 90 and 120 minutes.
Sample size:With a non-inferiority margin of 1.0 (50% of the minimal important difference), 600 participants would give a power of 0.9 (1- β) to establish non-inferiority of ketorolac vs. morphine (significance level α = 0.05).
- Conditions
- Acute Pain, Abdomen, Acute, Abdominal Pain, Appendicitis, Emergencies, Child, Only
- Being tested
- Ketorolac Tromethamine, Morphine Sulfate, normal saline
- Medical subject headings
- Acute Pain, Abdomen, Acute, Abdominal Pain, Appendicitis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Intravenous ketorolac given at 0.5 mg/kg of body weight up to a maximum of 30 mg in a single dose.
Morphine SulfateDrug
Intravenous morphine given at 0.1 mg/kg of body weight up to a maximum of 5 mg in a single dose.
normal salineDrug
Also called Morphine Sulfate Placebo
Intravenous normal saline placebo (labelled as morphine) given at 0.1 mg/kg of body weight up to a maximum of 5 mg in a single dose.
Normal salineDrug
Also called Ketorolac Tromethamine Placebo
Intravenous normal saline placebo (labelled as ketorolac) given at 0.5 mg/kg of body weight up to a maximum of 30 mg in a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac Tromethamine | Experimental | 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 in Canada for use to treat acute pain in the emergency department. Receives: Drug: Ketorolac Tromethamine; Drug: normal saline |
| Morphine Sulfate | Active comparator | An intravenous opioid that is commonly used as part of usual care for treament of pain in patients with acute abdominal pain and suspected appendicitis. Receives: Drug: Morphine Sulfate; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief as measured on the verbal numerical rating scale
Between group 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 (21)
Pain relief as measured on the verbal numerical rating scale
Between group mean differences in pain as measured on an 11-point verbal
Measured: 30 minutes post drug administration
Pain relief as measured on the verbal numerical rating scale
Between group mean differences in pain as measured on an 11-point verbal
Measured: 90 minutes post drug administration
Pain relief as measured on the verbal numerical rating scale
Between group mean differences in pain as measured on an 11-point verbal
Measured: 120 minutes post drug administration
Pain relief as measured on the verbal numerical rating scale
Between group mean differences in pain as measured on an 11-point verbal
Measured: 6 hours post drug administration
Pain relief as measured on the verbal numerical rating scale during the ultrasound diagnostic
score from 0-10 on verbal numerical rating scale
Measured: up to 6 hours post drug administration
Proportion who achieve the minimal important difference for pain relief
Proportion of participants who achieves the 2-point verbal Numerical Rating Scale minimal important difference pain score reduction
Measured: 60 minutes post drug administration
Proportion who achieve the minimal important difference for pain relief
Proportion of participants who achieves the 2-point verbal Numerical Rating Scale minimal important difference pain score reduction
Measured: 120 minutes post drug administration
Change in baseline pain category
Proportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe >7)
Measured: 30 minutes post drug administration
Change in baseline pain category
Proportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe >7)
Measured: 60 minutes post drug administration
Change in baseline pain category
Proportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe >7)
Measured: 90 minutes post drug administration
Change in baseline pain category
Proportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe >7)
Measured: 120 minutes post drug administration
Change in baseline pain category
Proportion of participants who change the severity of their baseline pain category. Pain categories on the verbal numerical rating scale as follows: mild = 0 to 4, moderate = 5 to 7, severe >7)
Measured: 6 hours post drug administration
Time to effective analgesia
Duration of time from time of drug administration to time at which a verbal Numerical Rating Scale ≤3 is achieved.
Measured: up to 6 hours post drug administration
Additional analgesia requirment
Proportion of participants requiring any additional analgesia in each trial arm
Measured: up to 6 hours post drug administration
Total opioids administered
total morphine-equivalent mg/kg administered for all trial participants
Measured: up to 8 hours post drug administration
Ramsay sedation score
Assessment of sedation levels post drug administration; score is 1-6 (1 is alert, 6 is not responsive)
Measured: 30 minutes post drug administration
Ramsay sedation score
Assessment of sedation levels post drug administration; score is 1-6 (1 is alert, 6 is not responsive)
Measured: 60 minutes post drug administration
Ramsay sedation score
Assessment of sedation levels post drug administration; score is 1-6 (1 is alert, 6 is not responsive)
Measured: 90 minutes post drug administration
Ramsay sedation score
Assessment of sedation levels post drug administration; score is 1-6 (1 is alert, 6 is not responsive)
Measured: 120 minutes post drug administration
Adverse events per participant
Frequency of specific adverse event occurrence per participant enrolled
Measured: up to 6 hours post drug administration
Frequency of each specific adverse event
Frequency of each specific adverse event occurrence
Measured: up to 6 hours post 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 2023
- Study start27 May 2024
- Primary completionJan 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Model description
- Two parallel interventional groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Mohamed Eltorki, MBChB, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160778
- Sponsor's protocol ID
- 23-0952
- Acronym
- KETOAPP
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the completion of the study and publication of main manuscript, anonymized participant data can be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Ketorolac Vs. Morphine In Children Presenting With Acute Abdominal Pain And/or Suspected Appendicitis: A Multi-centre Non-Inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06160778
- Acronym / sponsor ID
- KETOAPP / 23-0952
- Conditions
- Acute Pain, Abdomen, Acute, Abdominal Pain, Appendicitis, Emergencies, Child, Only
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 27 May 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 7 Dec 2023 (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.
Appendicitis is a common condition in children 6-17 years of age, and the top reason for emergency surgery in Canada. Children with appendicitis can have very bad pain in their belly. Children often need pain medications given to them through a needle in their arm called an intravenous (IV). The most common IV pain medication is a type of opioid called morphine. We know that opioids work well to improve pain, but there are risks and side effects when taking them. There are non-opioid medications that doctors can give to patients, like ketorolac. Ketorolac helps decrease inflammation and pain and has fewer side effects when a patient takes it for a short period of time. Our past and present overuse of opioids, driven by an unproven assumption that opioids work best for pain, resulted in an Opioid Crisis and doctors are now looking for alternatives. To do this, we need to prove that there are other options to treat children's pain that are just as good as opioids, with less side effects.
The goal of our study is to discover if school aged children who arrive at the emergency department with belly pain, improve just as much with ketorolac as they do with morphine. To answer this question, we will need a very large number of patients in a study that includes several hospitals across Canada. With a flip of a coin, each participant will either get a single dose of morphine or a single dose of ketorolac. To make sure that our pain assessment is impartial, no one will know which medicine the child received except the pharmacist who prepared the medicine.
Detailed description
Background: Appendicitis, the most common surgical diagnosis in Canadian children aged 6-17 years, accounts for ~8000 admissions annually. Despite an ongoing opioid crisis, prescription narcotics remain a mainstay analgesic for children with suspected appendicitis. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), which has a safer adverse event (AE) profile than opioids, is commonly used in emergency departments (EDs) for adults; however, use in children is considered off label due to a lack of randomized trials in this patient population. We propose a multi-centre clinical trial to address this knowledge gap,informed by our team's successful pilot trial.
Specific Aim 1: To determine if administering intravenous (IV) ketorolac is non inferior to IV morphine in reducing mean pain scores in children with suspected appendicitis.
Hypothesis: IV ketorolac will be non-inferior to IV morphine
Specific Aim 2: To determine between group differences in rates of AEs. Hypothesis: IV ketorolac will be associated with less AEs than IV morphine.
Design: A randomized quadruple blind (participant, clinician, outcome assessor, investigator) parallel group double-dummy trial in 4 Canadian pediatric EDs. Eligible patients will be 6-17 years with 5-days of moderate-severe pain (vNRS ≥5 ) being investigated for suspected appendicitis, with intravenous (IV) access, will be randomized to either:
- IV ketorolac 0.5 mg/kg up to 30 mg (intervention) + IV morphine placebo (normal saline), or
- IV morphine 0.1 mg/kg up to 5 mg (active control) + IV ketorolac placebo (normal saline).
Primary outcome: Between-group mean difference in pain on the vNRS at 60 minutes following administration.
Safety outcome: Proportion of children experiencing AEs related to study drug administration.
Secondary Outcomes: Between-group differences: (1) pain relief as measured on vNRS at 30, 90 and 120 minutes and at 6-8 hours; (2) proportion who achieves a 2-point vNRS (minimal important difference) pain score reduction at 60 and 120 minutes; (3) proportion of patients who change their baseline pain category (vNRS: mild 0-3, moderate 4-6, severe ≥7) at each time point; (4) time to effective analgesia as measured by the time when vNRS of <3 is achieved (5) proportion of patients requiring additional analgesia; (6) total opioids administered (i.e., morphine equivalent mg/kg within 8 hours of treatment); (7) frequency of specific types of AEs (e.g., dizziness); (8) frequency of delayed appendicitis diagnosis; and (9) Ramsay Sedation Score at 30, 60, 90 and 120 minutes.
Sample size:With a non-inferiority margin of 1.0 (50% of the minimal important difference), 600 participants would give a power of 0.9 (1- β) to establish non-inferiority of ketorolac vs. morphine (significance level α = 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel interventional groups.
| Arm | Type | Receives |
|---|---|---|
| Ketorolac Tromethamine | Experimental | Drug: Ketorolac Tromethamine, Drug: normal salineKetorolac 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 in Canada for use to treat acute pain in the emergency department. |
| Morphine Sulfate | Active comparator | Drug: Morphine Sulfate, Drug: Normal salineAn intravenous opioid that is commonly used as part of usual care for treament of pain in patients with acute abdominal pain and suspected appendicitis. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6 to 17 years
- Abdominal pain ≤5 days duration
- Acute abdominal pain that is being investigated (suspected) by the clinical team for appendicitis
- Patient with IV cannula in situ or ordered
- Currently experiencing moderate to severe abdominal pain at rest or with movement: self-reported pain score ≥5 using the verbal Numerical Rating Scale
Key exclusion criteria (12 listed)
- Previous enrollment in the trial
- NSAID use within 3 hours and/or opioid use within 1 to 2 hours (1 hour post-IV or intra-nasal fentanyl and 2 hours post IV morphine).
- Children who need immediate resuscitation, are hemodynamically unstable as deemed by the clinical team or have a Canadian Triage Assessment Score of 1
- Significant caregiver and/or child cognitive impairment precluding the ability to complete study questions.
- Chronic pain requiring daily analgesic use: confounding as response to analgesics maybe altered.
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 TromethamineIntravenous ketorolac given at 0.5 mg/kg of body weight up to a maximum of 30 mg in a single dose. | Drug | Ketorolac Tromethamine |
| Morphine SulfateIntravenous morphine given at 0.1 mg/kg of body weight up to a maximum of 5 mg in a single dose. | Drug | Morphine Sulfate |
| normal salineAlso: Morphine Sulfate PlaceboIntravenous normal saline placebo (labelled as morphine) given at 0.1 mg/kg of body weight up to a maximum of 5 mg in a single dose. | Drug | Ketorolac Tromethamine |
| Normal salineAlso: Ketorolac Tromethamine PlaceboIntravenous normal saline placebo (labelled as ketorolac) given at 0.5 mg/kg of body weight up to a maximum of 30 mg in a single dose. | Drug | Morphine Sulfate |
Primary outcome
Pain relief as measured on the verbal numerical rating scale
Time frame: 60 minutes post drug administration
Between group mean differences in pain as measured on an 11-point verbal Numerical Rating Scale (0 is no pain and 10 is worst pain ever)
21 secondary outcomes
Pain relief as measured on the verbal numerical rating scale
Time frame: 30 minutes post drug administration
Pain relief as measured on the verbal numerical rating scale
Time frame: 90 minutes post drug administration
Pain relief as measured on the verbal numerical rating scale
Time frame: 120 minutes post drug administration
Pain relief as measured on the verbal numerical rating scale
Time frame: 6 hours post drug administration
Pain relief as measured on the verbal numerical rating scale during the ultrasound diagnostic
Time frame: up to 6 hours post drug administration
Proportion who achieve the minimal important difference for pain relief
Time frame: 60 minutes post drug administration
Proportion who achieve the minimal important difference for pain relief
Time frame: 120 minutes post drug administration
Change in baseline pain category
Time frame: 30 minutes post drug administration
Change in baseline pain category
Time frame: 60 minutes post drug administration
Change in baseline pain category
Time frame: 90 minutes post drug administration
Change in baseline pain category
Time frame: 120 minutes post drug administration
Change in baseline pain category
Time frame: 6 hours post drug administration
Time to effective analgesia
Time frame: up to 6 hours post drug administration
Additional analgesia requirment
Time frame: up to 6 hours post drug administration
Total opioids administered
Time frame: up to 8 hours post drug administration
Ramsay sedation score
Time frame: 30 minutes post drug administration
Ramsay sedation score
Time frame: 60 minutes post drug administration
Ramsay sedation score
Time frame: 90 minutes post drug administration
Ramsay sedation score
Time frame: 120 minutes post drug administration
Adverse events per participant
Time frame: up to 6 hours post drug administration
Frequency of each specific adverse event
Time frame: up to 6 hours post drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: Yes. At the completion of the study and publication of main manuscript, anonymized participant data can be shared upon reasonable request.
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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.
Mohamed Eltorki, MBChB principal investigator
University of Calgary
1 site 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, Morphine Sulfate and normal saline in people with Acute Pain and Abdomen, Acute, run by University of Calgary at 1 site 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M Eltorki, MBChB, MSc (+1403-955-7723, mmeltork@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief as measured on the verbal numerical rating scale (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?
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 24 Jun 2024.