PainPhase 1NCT03017248
Low-dose Ketamine for Acute Pain in the Emergency Department
A Phase 1 study testing Ketamine and Morphine in people with Pain, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
Trial summary
This study aims to determine the efficacy and safety of low dose ketamine in association with IV morphine in the management of acute moderate to severe pain in emergency department. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Ketamine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteTunisia
- Study dates
- Jan 2016to Mar 2017
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and give informed consent
- Comfortable with the experimental protocol as outlined to them by the research team
- Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
- Acute pain, pain duration < 7days
- Deemed by treating ED attending physician to require IV opioid analgesia
Who cannot join
- Neurologic, respiratory, or hemodynamic compromise
- Pregnancy or breastfeeding
- Known or suspected allergy to ketamine or morphine
- Known Renal (Cr>2.0) or Liver Failure
- Unstable psychiatric disease (as per treating physician)
- History of stroke
- History of cardiac disease or coronary artery disease
- History of chronic respiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit of the Association of Low Doses of Ketamine With Intravenous Morphine in the Treatment of Acute Severe Pain in Emergency Department
This study aims to determine the efficacy and safety of low dose ketamine in association with IV morphine in the management of acute moderate to severe pain in emergency department.
The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.
Read the detailed description
Management of pain in the Emergency Department is challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, the use of opioids alone for pain control is often associated with inadequate analgesia and increased adverse events.
Low-dose ketamine has been shown to improve pain perception and produce an opioid-sparing effect when given perioperatively.
Its use in the ED may probably play a role in maximizing analgesia.
- Conditions
- Pain
- Keywords
- pain, ketamine, morphine, analgesia, emergency
- Medical subject headings
- Pain, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar, 50 Mg/mL Injectable Solution
ketamine
PlacebosDrug
Also called Normal Saline Flush, 0.9% Injectable Solution
0.9% normal saline
MorphineDrug
Also called Morphine Sulfate
Morphine
| Study group | Role | What they receive |
|---|---|---|
| Morphine and Placebo | Active comparator | Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg) Receives: Drug: Placebos; Drug: Morphine |
| Morphine and Ketamine 0.15 | Experimental | Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg Receives: Drug: Ketamine; Drug: Morphine |
| Morphine and Ketamine 0.3 | Experimental | Morphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg Receives: Drug: Ketamine; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of analgesia: To assess the primary outcome of pain relief, we used patient-reported pain scores. We consider the pain decreasing of at least 50% of pain score and the summed pain-intensity difference (SPID) over 2 hours
At baseline, to assess our primary aim, efficacy of pain control, we will use patient reported pain scores and amount of rescue analgesia (parenteral morphine) received. Trained residents will ask participants to report their pains scores using a numerical pain rating scale (NPRS). The NPRS used will be a 0 to 10 rating scale. Baseline NPRS will be measured after randomization, but just before administration of morphine. Change in reported pain score during the protocol will be analysed.
The SPID was calculated using the pain-intensity difference (PID) at each of these study time points. The PID for a given time point is equal to the baseline NPRS minus the subsequent NPRS at each study time point. SPID is the summation of the PID at each of the study time points, weighted using the amount of time since the prior assessment
Measured: Two hours after starting protocol
Secondary outcomes (5)
Total patient-perceived pain relief
The total patient-perceived pain relief will be calculated using weighted sum of the pain relief scale performed at each study time point. This pain relief scale is a five-point scale that asks participants to rate pain relief as complete = 4, a lot = 3, some = 2, a little = 1, and none = 0
Measured: Two hours after starting protocol
Amount of rescue analgesia received
The amount of rescue analgesia received (in milligrams of morphine equivalents) will be recorded.
Measured: Two hours after starting protocol
Time to rescue analgesia
Time to rescue analgesia will be calculated as the time from administration of the last study medication (placebo or ketamine) to administration of an opioid analgesic.
Measured: Two hours after starting protocol
The occurrence of adverse events
We will record participant-reported dizziness, nausea, vomiting, confusion, dysphoria, visual disturbances, or other complaints at baseline and each study time point. All patients will be monitored for the duration of the study period and vital signs will be recorded at each time point.
The presence of tachycardia (heart rate > 100 beats/min.), hypotension (systolic blood pressure [sBP] < 100 mm Hg), hypertension (sBP > 180 mm Hg or diastolic blood pressure [dBP] > 100 mm Hg), and respiratory depression (respiratory rate < 12 breaths/min, oxygen saturation < 92%, or need for supplemental oxygen) will be noted.
Measured: Two hours after starting protocol
The total dose of morphine administered
The amount of rescue analgesia will be recorded at each time point and the total dose calculated
Measured: Two hours after starting protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAJER KRAIEM, Faculty of Medicine, Sousse
- Investigators
- Hajer KRAIEM, MD, Principal investigator, Faculty of medicine of Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017248
- Sponsor's protocol ID
- FMSousse
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of the Association of Low Doses of Ketamine With Intravenous Morphine in the Treatment of Acute Severe Pain in Emergency Department
- ClinicalTrials.gov ID
- NCT03017248
- Acronym / sponsor ID
- FMSousse
- Conditions
- Pain
- Keywords
- pain, ketamine, morphine, analgesia, emergency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 11 Jan 2017 (estimated)
- 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.
This study aims to determine the efficacy and safety of low dose ketamine in association with IV morphine in the management of acute moderate to severe pain in emergency department.
The investigators hypothesize that low dose ketamine will result in more effective pain control than morphine alone and will not be associated with an increase in adverse events.
Detailed description
Management of pain in the Emergency Department is challenging. Treatment of pain is most often accomplished by parenteral opioids analgesics. However, the use of opioids alone for pain control is often associated with inadequate analgesia and increased adverse events.
Low-dose ketamine has been shown to improve pain perception and produce an opioid-sparing effect when given perioperatively.
Its use in the ED may probably play a role in maximizing analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morphine and Placebo | Active comparator | Drug: Placebos, Drug: MorphineMorphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an injection of Placebos (0.9% normal saline 0.05ml/kg) |
| Morphine and Ketamine 0.15 | Experimental | Drug: Ketamine, Drug: MorphineMorphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.15mg/kg |
| Morphine and Ketamine 0.3 | Experimental | Drug: Ketamine, Drug: MorphineMorphine IV, Dose: 0.1 mg/Kg followed 10 minutes later by an IV bolus of Ketamine at the dose of 0.3mg/kg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and give informed consent
- Comfortable with the experimental protocol as outlined to them by the research team
- Severe pain, pain score of at least 50/100 on Visual Analogue Scale (VAS) or 5/10 numerical ratings score
- Acute pain, pain duration < 7days
- Deemed by treating ED attending physician to require IV opioid analgesia
Key exclusion criteria (8 listed)
- Neurologic, respiratory, or hemodynamic compromise
- Pregnancy or breastfeeding
- Known or suspected allergy to ketamine or morphine
- Known Renal (Cr>2.0) or Liver Failure
- Unstable psychiatric disease (as per treating physician)
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 |
|---|---|---|
| KetamineAlso: Ketalar, 50 Mg/mL Injectable Solutionketamine | Drug | Morphine and Ketamine 0.15, Morphine and Ketamine 0.3 |
| PlacebosAlso: Normal Saline Flush, 0.9% Injectable Solution0.9% normal saline | Drug | Morphine and Placebo |
| MorphineAlso: Morphine SulfateMorphine | Drug | Morphine and Ketamine 0.15, Morphine and Ketamine 0.3, Morphine and Placebo |
Primary outcome
Efficacy of analgesia: To assess the primary outcome of pain relief, we used patient-reported pain scores. We consider the pain decreasing of at least 50% of pain score and the summed pain-intensity difference (SPID) over 2 hours
Time frame: Two hours after starting protocol
At baseline, to assess our primary aim, efficacy of pain control, we will use patient reported pain scores and amount of rescue analgesia (parenteral morphine) received. Trained residents will ask participants to report their pains scores using a numerical pain rating scale (NPRS). The NPRS used will be a 0 to 10 rating scale. Baseline NPRS will be measured after randomization, but just before administration of morphine. Change in reported pain score during the protocol will be analysed. The SPID was calculated using the pain-intensity difference (PID) at each of these study time points. The PID for a given time point is equal to the baseline NPRS minus the subsequent NPRS at each study time point. SPID is the summation of the PID at each of the study time points, weighted using the amount of time since the prior assessment
5 secondary outcomes
Total patient-perceived pain relief
Time frame: Two hours after starting protocol
Amount of rescue analgesia received
Time frame: Two hours after starting protocol
Time to rescue analgesia
Time frame: Two hours after starting protocol
The occurrence of adverse events
Time frame: Two hours after starting protocol
The total dose of morphine administered
Time frame: Two hours after starting protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Hajer KRAIEM, MD principal investigator
Faculty of medicine of Sousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine and Morphine in people with Pain, run by Faculty of Medicine, Sousse at 1 site in Tunisia.
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 8 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 31 Jan 2017. 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 Tunisia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Efficacy of analgesia: To assess the primary outcome of pain relief, we used patient-reported pain scores. We consider the pain decreasing of at least 50% of pain score and the summed pain-intensity difference (SPID) over 2 hours (time frame: Two hours after starting protocol). 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 31 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.