Acute PainPhase 3NCT04013958
Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic
A Phase 3 study testing IV Ketamine and IM Ketamine in people with Acute Pain and Renal Colic, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Patients who present to the emergency department (ED), with acute pain due to renal colic, are often treated with opioids. Treatment with opioids has many disadvantages - cardio-respiratory depression, nausea, vomiting and long term dependence. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pain, Renal Colic
- What is being tested?
- IV Ketamine and IM Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2019to 1 Aug 2021
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Self-report pain greater than or equal to 7/10 on a numerical-verbal scale
- Weigh 50-100 kg
- Have systolic blood pressure of 90-180 mmHg
- Have an ASA (American Society of Anaesthesiologists' classification) score of 1-2
Who cannot join
- Have had opioid analgesia administered within 6 hours of the study
- Are chronic analgesia users (of opioid or others)
- Have known allergies to morphine or ketamine
- Are pregnant
- Have a psychiatric history
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center, department of Emergency Medicine
Tel Aviv, 6423906
About this study
Patients who present to the emergency department (ED), with acute pain due to renal colic, are often treated with opioids. Treatment with opioids has many disadvantages - cardio-respiratory depression, nausea, vomiting and long term dependence. For these reasons, there is a constant search for a way to reduce the use of opioids. ketamine has been proven to augmented the analgesic effect of opioids, and thus reduce the use and adverse effects of opioids. Different studies about the use of Ketamine as a sedition agent have shown that Ketamine given IM versus IV has longer duration of effect with less adverse effects.
The study we are conducting is designed to test and analyze the safety and efficacy of IV Ketamine with IV Morphine compared to IV Ketamine and morphine with IM placebo in a setting of acute pain due to, or suspected renal colic in the ED. When both ways of administration are given by the protocol as is customary for treatment of pain in the Emergency Medicine department, and will be a prospective, randomized, double blind, controlled study.
Read the detailed description
The procedure:
- Eligible patients will be identified by the ED personnel.
- Research physician will address the patient, explain about the trial and ask the patient to sign a consent form.
- The patient will be randomized and assigned to a trial group: "A" or "B" and it will be noted in the Data sheet.
- According to physician order (IV amount and IM amount) and patient group assignment, the nurse will prepare and administer the different drugs.
- Patients in group "A" wiil receive IV Ketamine with IV morphine and IM placebo of normal saline. Patients in group "B" wiil receive IM Ketamine with IV morphine.
- The amount will be calculated based on the patients' weight: IV Morphine -0.1 mg/kg: Morphine vial contains 10 mg/10 ml. IV Ketamine -0.1 mg/kg: Ketamine vial contains 50 mg/1 ml. IM Ketamine -0.25 mg/kg: Ketamine vial contains 50 mg/1 ml.
- Prior to administering medication to the patient a research assistant, who is blinded to the choice of drugs given, will measure vital signs (blood pressure, heart rate and O2 saturation) as well as pain level on a 100 mm VAS (visual analogue scale) questionnaire.
- After administration of medications the researcher assistant will measure vital signs (blood pressure, heart rate and O2 saturation) as well as pain level on a 100 mm VAS questionnaire, at 5 and 10 minutes after administration, and then at 30, 45, 60, and 90 minutes.
- Measurement of vital signs will not interfere with any other treatment that the patients receives for their injury in the ED.
- Cardiorespiratory follow-up (as per bullet point number 8 above), will be concluded at 1.5 hours post-intervention, and clinical follow-up will continue as long as the patient remains in the ED.
- During the time of the the followup and after, if pain had not subsided sufficiently according to treating physician's clinical assessment, patient will receive further analgesic medications by physician order, as per ED protocol. The protocol takes into account concurrent medications.
- Conditions
- Acute Pain, Renal Colic
- Being tested
- IV Ketamine, IM Ketamine
- Keywords
- Morphine, Ketamine, Renal colic
- Medical subject headings
- Acute Pain, Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV KetamineDrug
Also called No other
IV Ketamine 0.1 mg/kg with IV morphine -0.1 mg/kg with IM Sailne 0.9%
IM KetamineDrug
IM Ketamine 0.3 mg/kg with IV morphine -0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| IV Ketamine | Active comparator | IV Ketamine group will receive IV Ketamine with IV morphine and IM saline. Receives: Drug: IV Ketamine |
| IM Ketamine | Experimental | IM Ketamine group will receive IM Ketamine with IV morphine. Receives: Drug: IM Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of IM Ketamine in decreasing pain intensity [patient assessed - VAS pain score]
Time to achieve a clinically meaningful pain reduction was defined as the first time-point at which the patient reported 15mm of pain reduction or more. Maximal pain reduction was defined as the lowest VAS score reported by the patient over the course of follow-up. Time to maximal pain reduction was defined as the time at which the patient has the lowest VAS score over the course of the 1.5 hours follow-up.
Measured: 1.5 hour post administration
Adverse effects [Opiate Related Symptom Distress Scale]
adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 1.5 hour post administration ]
Measured: 1.5 hour post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (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 Tel-Aviv Sourasky Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomized according to a blocked randomization scheme "WWW.RANDOMIZATION.COM" , which permits assignment of the participant to either group "A" or "group B" (the IM ketamine+IV morphine group or IV ketamine+IV morphine with IM saline (placebo) group. Eligible patients will be divided in equal proportions (50 in group A and 50 in group B).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013958
- Sponsor's protocol ID
- TASMC-19-DT-0060-19-CTIL
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: a table summering pain assessing questioners will be available from corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment by IM Ketamine to IV Ketamine in Patients With Renal Colic
- ClinicalTrials.gov ID
- NCT04013958
- Acronym / sponsor ID
- TASMC-19-DT-0060-19-CTIL
- Conditions
- Acute Pain, Renal Colic
- Keywords
- Morphine, Ketamine, Renal colic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 10 Jul 2019 (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.
Patients who present to the emergency department (ED), with acute pain due to renal colic, are often treated with opioids. Treatment with opioids has many disadvantages - cardio-respiratory depression, nausea, vomiting and long term dependence. For these reasons, there is a constant search for a way to reduce the use of opioids. ketamine has been proven to augmented the analgesic effect of opioids, and thus reduce the use and adverse effects of opioids. Different studies about the use of Ketamine as a sedition agent have shown that Ketamine given IM versus IV has longer duration of effect with less adverse effects.
The study we are conducting is designed to test and analyze the safety and efficacy of IV Ketamine with IV Morphine compared to IV Ketamine and morphine with IM placebo in a setting of acute pain due to, or suspected renal colic in the ED. When both ways of administration are given by the protocol as is customary for treatment of pain in the Emergency Medicine department, and will be a prospective, randomized, double blind, controlled study.
Detailed description
The procedure:
- Eligible patients will be identified by the ED personnel.
- Research physician will address the patient, explain about the trial and ask the patient to sign a consent form.
- The patient will be randomized and assigned to a trial group: "A" or "B" and it will be noted in the Data sheet.
- According to physician order (IV amount and IM amount) and patient group assignment, the nurse will prepare and administer the different drugs.
- Patients in group "A" wiil receive IV Ketamine with IV morphine and IM placebo of normal saline. Patients in group "B" wiil receive IM Ketamine with IV morphine.
- The amount will be calculated based on the patients' weight: IV Morphine -0.1 mg/kg: Morphine vial contains 10 mg/10 ml. IV Ketamine -0.1 mg/kg: Ketamine vial contains 50 mg/1 ml. IM Ketamine -0.25 mg/kg: Ketamine vial contains 50 mg/1 ml.
- Prior to administering medication to the patient a research assistant, who is blinded to the choice of drugs given, will measure vital signs (blood pressure, heart rate and O2 saturation) as well as pain level on a 100 mm VAS (visual analogue scale) questionnaire.
- After administration of medications the researcher assistant will measure vital signs (blood pressure, heart rate and O2 saturation) as well as pain level on a 100 mm VAS questionnaire, at 5 and 10 minutes after administration, and then at 30, 45, 60, and 90 minutes.
- Measurement of vital signs will not interfere with any other treatment that the patients receives for their injury in the ED.
- Cardiorespiratory follow-up (as per bullet point number 8 above), will be concluded at 1.5 hours post-intervention, and clinical follow-up will continue as long as the patient remains in the ED.
- During the time of the the followup and after, if pain had not subsided sufficiently according to treating physician's clinical assessment, patient will receive further analgesic medications by physician order, as per ED protocol. The protocol takes into account concurrent medications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be randomized according to a blocked randomization scheme "WWW.RANDOMIZATION.COM" , which permits assignment of the participant to either group "A" or "group B" (the IM ketamine+IV morphine group or IV ketamine+IV morphine with IM saline (placebo) group. Eligible patients will be divided in equal proportions (50 in group A and 50 in group B).
| Arm | Type | Receives |
|---|---|---|
| IV Ketamine | Active comparator | Drug: IV KetamineIV Ketamine group will receive IV Ketamine with IV morphine and IM saline. |
| IM Ketamine | Experimental | Drug: IM KetamineIM Ketamine group will receive IM Ketamine with IV morphine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70
- Self-report pain greater than or equal to 7/10 on a numerical-verbal scale
- Weigh 50-100 kg
- Have systolic blood pressure of 90-180 mmHg
- Have an ASA (American Society of Anaesthesiologists' classification) score of 1-2
Key exclusion criteria (5 listed)
- Have had opioid analgesia administered within 6 hours of the study
- Are chronic analgesia users (of opioid or others)
- Have known allergies to morphine or ketamine
- Are pregnant
- Have a psychiatric history
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 |
|---|---|---|
| IV KetamineAlso: No otherIV Ketamine 0.1 mg/kg with IV morphine -0.1 mg/kg with IM Sailne 0.9% | Drug | IV Ketamine |
| IM KetamineIM Ketamine 0.3 mg/kg with IV morphine -0.1 mg/kg | Drug | IM Ketamine |
Primary outcome
Effectiveness of IM Ketamine in decreasing pain intensity [patient assessed - VAS pain score]
Time frame: 1.5 hour post administration
Time to achieve a clinically meaningful pain reduction was defined as the first time-point at which the patient reported 15mm of pain reduction or more. Maximal pain reduction was defined as the lowest VAS score reported by the patient over the course of follow-up. Time to maximal pain reduction was defined as the time at which the patient has the lowest VAS score over the course of the 1.5 hours follow-up.
Adverse effects [Opiate Related Symptom Distress Scale]
Time frame: 1.5 hour post administration
adverse effects [Opiate Related Symptom Distress Scale] [ Time Frame: 1.5 hour post administration ]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: Yes. a table summering pain assessing questioners will be available from corresponding author on 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. This study is not recruiting at the moment.
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 IV Ketamine and IM Ketamine in people with Acute Pain and Renal Colic, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Trotzky, MD (+97236973829, danieltro@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of IM Ketamine in decreasing pain intensity [patient assessed - VAS pain score] (time frame: 1.5 hour post administration). The study lists 2 primary outcomes in all. 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 10 Jul 2019.