Pain, AcutePhase 2NCT04061330
Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
A Phase 2 study testing Ketamine and Morphine in people with Pain, Acute, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Ketamine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.
Who cannot join
- Received morphine in the ED prior to enrollment
- Received ketamine any time prior to enrollment
- Glasgow Coma Scale(GCS) less than 15
- Transferred from other facility
- Other moderate to severe trauma injuries
- Contraindication to ketamine
Show all 9Show fewer
- Cannot consent (no intubation, airway issues, hemodynamic instability)
- Prisoners
- Suspected and/or confirmed pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.
- Conditions
- Pain, Acute
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Initial bolus of ketamine 0.3 mg/kg IV (maximum 30 mg) followed by ketamine infusion of 0.25mg/kg/hr (maximum 25mg/kg/hr) for 6 hours or until patient leaves the emergency department (ED),whichever occurs first.
MorphineDrug
Bolus doses of morphine 0.1 mg/kg (maximum 8 mg) intravenously every 2 hours for 6 hours or until patient leaves the ED, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Experimental | Not described Receives: Drug: Ketamine |
| Opioid group | Active comparator | Not described Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: baseline
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 5 minutes after initial administration of drug
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 10 minutes after initial administration of drug
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 30 minutes after initial administration of drug
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 60 minutes after initial administration of drug
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 2 hours after initial administration of drug
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 3 hours after initial administration of drug
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 4 hours after initial administration of drug
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 5 hours after initial administration of drug
Clinical pain as assessed by the Numerical pain rating score (NPRS)
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Measured: 6 hours after initial administration of drug
Secondary outcomes (33)
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 5 minutes after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 10 minutes after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 30 minutes after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 60 minutes after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 2 hours after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 3 hours after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 4 hours after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 5 hours after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Hypoxic episodes occur when peripheral capillary oxygen saturation (SPO2) is less than 90 percent as measured by a continuous pulse oximeter.
Measured: 6 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 5 minutes after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 10 minutes after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 30 minutes after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 60 minutes after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 2 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 3 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 4 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 5 hours after initial administration of drug
Number of hypotension episodes
Hypotension occurs when systolic blood pressure (SBP) is less than 100mmHg
Measured: 6 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 5 minutes after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 10 minutes after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 30 minutes after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 60 minutes after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 2 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 3 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 4 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 5 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
The RASS is a 10-point scale ranging from +4 to -5, with four levels of anxiety or agitation (+4 to +1), one level denoting a calm and alert state (0), and 5 levels of sedation (-1 to -5). +4 represents a very combative, violent patient, and on the other extreme -5 represents a patient who is unarousable, with no response to voice or physical stimulation.
Measured: 6 hours after initial administration of drug
Number of participants with need for rescue opioid therapy
Measured: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
Number of participants with need for rescue benzodiazepine therapy in ketamine group for emergence phenomenon and dysphoria
Measured: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
Number of participants with Adverse reactions
Measured: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
Patient satisfaction with analgesia
Patient satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Measured: end of treatment (about 6 hours after initial administration of drug)
Physician satisfaction with analgesia
Physician satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Measured: end of treatment (about 6 hours after initial administration of drug)
Nursing satisfaction with analgesia
Nursing satisfaction will be measured on a 5 point scale, with 1 being very unsatisfied and 5 being very satisfied.
Measured: end of treatment (about 6 hours after initial administration of drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Study was terminated prior to enrollment due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulina Sergot, The University of Texas Health Science Center, Houston
- Investigators
- Paulina Sergot, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061330
- Sponsor's protocol ID
- HSC-MS-19-0580
- Status last verified
- Apr 2022
- First submitted
- 15 Aug 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low-dose Ketamine to Opioids in the Management of Acute Pain in Patients Presenting to the Emergency Department With Long Bone Fractures
- ClinicalTrials.gov ID
- NCT04061330
- Acronym / sponsor ID
- HSC-MS-19-0580
- Conditions
- Pain, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was terminated prior to enrollment due to lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Aug 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.
The purpose of this study is to establish the feasibility of initiating a ketamine pain control protocol in the emergency department for the treatment of acute pain in patients with long bone fractures and to compare the efficacy of the ketamine pain protocol to bolus morphine for pain control in the first 6 hours of patient stay in the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Experimental | Drug: Ketamine |
| Opioid group | Active comparator | Drug: Morphine |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients presenting to the ED with long bone fracture, open or closed.Long bone fractures include:humerus, radius, ulna, femur, tibia, fibula.
Key exclusion criteria (9 listed)
- Received morphine in the ED prior to enrollment
- Received ketamine any time prior to enrollment
- Glasgow Coma Scale(GCS) less than 15
- Transferred from other facility
- Other moderate to severe trauma injuries
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 |
|---|---|---|
| KetamineInitial bolus of ketamine 0.3 mg/kg IV (maximum 30 mg) followed by ketamine infusion of 0.25mg/kg/hr (maximum 25mg/kg/hr) for 6 hours or until patient leaves the emergency department (ED),whichever occurs first. | Drug | Ketamine Group |
| MorphineBolus doses of morphine 0.1 mg/kg (maximum 8 mg) intravenously every 2 hours for 6 hours or until patient leaves the ED, whichever occurs first. | Drug | Opioid group |
Primary outcome
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: baseline
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 5 minutes after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 10 minutes after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 30 minutes after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 60 minutes after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 2 hours after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 3 hours after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 4 hours after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 5 hours after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
Clinical pain as assessed by the Numerical pain rating score (NPRS)
Time frame: 6 hours after initial administration of drug
The NPRS total score ranges form 0-10,0 being no pain and 10 being worst possible pain.
33 secondary outcomes
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 5 minutes after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 10 minutes after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 30 minutes after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 60 minutes after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 2 hours after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 3 hours after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 4 hours after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 5 hours after initial administration of drug
Number of hypoxic episodes as measured with a continuous pulse oximeter
Time frame: 6 hours after initial administration of drug
Number of hypotension episodes
Time frame: 5 minutes after initial administration of drug
Number of hypotension episodes
Time frame: 10 minutes after initial administration of drug
Number of hypotension episodes
Time frame: 30 minutes after initial administration of drug
Number of hypotension episodes
Time frame: 60 minutes after initial administration of drug
Number of hypotension episodes
Time frame: 2 hours after initial administration of drug
Number of hypotension episodes
Time frame: 3 hours after initial administration of drug
Number of hypotension episodes
Time frame: 4 hours after initial administration of drug
Number of hypotension episodes
Time frame: 5 hours after initial administration of drug
Number of hypotension episodes
Time frame: 6 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 5 minutes after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 10 minutes after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 30 minutes after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 60 minutes after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 2 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 3 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 4 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 5 hours after initial administration of drug
Score on Richmond Agitation-Sedation Scale (RASS)
Time frame: 6 hours after initial administration of drug
Number of participants with need for rescue opioid therapy
Time frame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
Number of participants with need for rescue benzodiazepine therapy in ketamine group for emergence phenomenon and dysphoria
Time frame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
Number of participants with Adverse reactions
Time frame: from time of initial administration of drug to end of treatment (about 6 hours after initial administration of drug)
Patient satisfaction with analgesia
Time frame: end of treatment (about 6 hours after initial administration of drug)
Physician satisfaction with analgesia
Time frame: end of treatment (about 6 hours after initial administration of drug)
Nursing satisfaction with analgesia
Time frame: end of treatment (about 6 hours after initial administration of drug)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Paulina Sergot, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Morphine in people with Pain, Acute, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 1 inclusion and 9 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: withdrawn, as of the sponsor's last update on 27 Apr 2022. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical pain as assessed by the Numerical pain rating score (NPRS) (time frame: baseline). The study lists 10 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 27 Apr 2022.