SCDFLASCNCT07188766
Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis
A study testing Sodium Chloride (NaCl) 0.9 % in people with SCD and Vaso Occlussive Crisis, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
Trial summary
Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- SCD, Vaso Occlussive Crisis
- What is being tested?
- Sodium Chloride (NaCl) 0.9 %
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 5 Oct 2025to Oct 2028
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients >18 years old with a confirmed diagnosis of SCD.
- Presenting with a VOC.
- NPRS >5
- Willingness to participate and provide informed consent.
Who cannot join
- Patient requiring specialized IVF management as per the treating physician discretion.
- Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure
- Patients with ESRD on chronic dialysis
- Patients with signs of shock (low SBP <100 or MAP < 65) and signs of hypo perfusion
- Known or suspected pregnancy
- Previously enrolled in this trial within the last 30 days
- Enrolled in another trial study that interfered with fluid management
- Unable to obtain IV access.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laila Perlas Asonto, RN contact
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Fahd Hospital of the University
Dammam, Eastern Province, 31952
Mohammed S Alshahrani, MD, +966556966663, msshahrani@iau.edu.sa
Laila P Asonto, RN, +966554586033, lasonto@iau.edu.sa
- Recruiting
King Saud University Medical City
Riyadh
Hassan Alshaqaq, MD, 966544509443, hassan.m.alshaqaq@gmail.com
About this study
Official title: Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)
Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain. This study evaluates restrictive versus liberal fluid management strategies in patients with acute VOC.
This multi-center, open-label, non-inferiority RCT will enroll patients with SCD presenting with acute VOC. Participants will be randomized to either a restrictive or liberal intravenous fluid management protocol. Primary outcome is pain score reduction. Secondary outcomes include time to pain resolution, ED length of stay, hospital admission rate, cumulative opioid dose, adverse events (incidence of fluid overload, pulmonary congestion), acute chest syndrome, incidence of acute kidney injury, revisit rates within 72 hours of ED discharge, need for intensive care or high-dependency unit admission, need for additional interventions, and 28 days overall mortality. Data will be analyzed using intention-to-treat principles.
We hypothesize that a restrictive fluid strategy will achieve non-inferior pain control compared to a liberal strategy, while minimizing fluid-related complications. This study will provide evidence to inform clinical guidelines for fluid management in SCD patients experiencing VOCs.
Read the detailed description
This study is a prospective, non-inferiority, open-label, multicenter randomized-controlled trial (RCT) conducted in the emergency departments (EDs) of tertiary care hospitals in Saudi Arabia. The primary objective is to compare two fluid management strategies- restrictive (intervention) vs. liberal (control) in adult sickle cell disease (SCD) patients hospitalized for VOC. The study evaluates whether a restrictive fluid approach is non-inferior to a liberal strategy in terms of pain resolution, hospitalization duration, and other clinical outcomes.
Patients will be randomized upon ED admission, and their assigned fluid regimen will be administered within the first hour. Clinical teams will monitor outcomes throughout hospitalization or up to 28 days post-enrollment.
Study Population
- Recruitment Screening: All patients admitted to the ED with VOC will be screened for eligibility. Consent Model: A priori informed written consent will be obtained from conscious, coherent patients or substitute decision-makers.
- Inclusion Criteria Age >18 years with confirmed SCD diagnosis. Presenting with VOC requiring hospitalization. Numeric Pain Rating Scale (NPRS) >5 Willingness to participate and provide informed consent.
- Exclusion Criteria Requiring specialized IVF management per the physician's discretion.
Cardiac/Renal Conditions:
Congestive heart failure (CHF) or symptomatic systolic heart failure.
Patients with ESRD on chronic dialysis.
Hemodynamic Instability:
Shock (SBP <100 mmHg or MAP <65) with hypoperfusion signs.
Other Exclusions:
Known/suspected pregnancy.
Prior enrollment in this trial within the last 30 days.
Concurrent enrollment in another trial affecting fluid management.
Inability to obtain IV access.
Trial Intervention
- Screening \& Randomization Screening occurs upon ED admission; evaluations must precede randomization. A screening log will track eligible vs. randomized patients.
- Informed Consent An a priori consent model is used due to the conscious-coherent state of most SCD patients in VOC. Efforts will be made to obtain consent immediately from the patient or surrogate.
- Intervention Arms A. Intervention (Restrictive)Keep-vein-open (KVO) rate only (minimal fluids to maintain IV patency). No additional IV fluids administered.
- Control (Liberal) 20 mL/kg IV bolus (NS or LR over 1 hour) + maintenance fluids (1.5-2 mL/kg/day).
Initiation: Both regimens starts within 1 hour of ED admission and continue until ED discharge.
Hospitalized Patients:
Pain scores (NPRS) recorded at 24, 48, and 72 hours. Total fluid intake documented at hospital discharge.
- Conditions
- SCD, Vaso Occlussive Crisis
- Being tested
- Sodium Chloride (NaCl) 0.9 %
- Keywords
- sickle cell disease, sickle cell crisis, intravenous fluid, emergency department
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride (NaCl) 0.9 %Drug
Also called Restricted
Keep vein open rate
Sodium Chloride (NaCl) 0.9 %Drug
Also called Liberal
IV bolus of 20 mL/kg of normal saline over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements
| Study group | Role | What they receive |
|---|---|---|
| Restricted approach group | Experimental | Patients in this arm will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered Receives: Drug: Sodium Chloride (NaCl) 0.9 % |
| Liberal Approach Group | Active comparator | Patients will receive an IV bolus of 20 mL/kg of normal saline or lactated Ringer's over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements Receives: Drug: Sodium Chloride (NaCl) 0.9 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity
Measured using the Numeric Pain Rating Scale (NPRS)
Measured: Baseline (within 30 minutes post admission), 1 hour, then hourly until ED discharge or 24- 48- and 72-hours post-admission ( for admitted patients)
Secondary outcomes (7)
Time to pain resolution
NPRS score of ≤5
Measured: up to 4 hours
ED length of stay
time elapsed from ED admission to ED discharge or admit to the wards
Measured: at least 4 hours
Hospital admission rate
Proportion of participants requiring inpatient admission
Measured: within 24 hours of ED admission
Cumulative Opioid Dose
Total opioid consumption during acute VOC episode
Measured: up to 4 hours
Revisit Rates
Percentage of patients who revisited the emergency department
Measured: within 72 hours post ED discharge
Overall Mortality
number of patients who died
Measured: within 28 days post-enrollment
Adverse events
total number of patients who encountered allergic reactions, respiratory distress, pulmonary edema, and acute chest syndrome, development of tachypnea, hypoxia, cough, crackles on auscultation, elevated BP, need for respiratory support, heart failure (worsening of tachycardia, hepatomegaly, peripheral edema, and allergic reactions (urticaria, angioedema, hypotension, wheezing)
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start5 Oct 2025
- Primary completionAug 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SCDStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, non-inferiority, open label multicenter randomized controlled trial. Patients on Intervention Group (Restricted approach group) will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered. Control Group (Liberal Approach Group) Patients will receive an IV bolus of 20 mL/kg of normal saline or lactated Ringer's over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements.
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Saeed Saad Alshahrani, Imam Abdulrahman Bin Faisal University
- Investigators
- Mohammed S Alshahrani, MD, Principal investigator, King Fahd Hospital of the University- Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188766
- Sponsor's protocol ID
- 2025-01-0451
- Acronym
- FLASC
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Demographics: Age, sex, and other baseline characteristics. 2. Outcome Measures: primary and secondary outcomes of the trial. 3. Adverse Events: Data on side effects or other adverse events participants experienced during the trial. 4. Treatment Allocations: Information on which participants were assigned to each treatment group.
Publications
Puri L, Nottage KA, Hankins JS, Anghelescu DL. State of the Art Management of Acute Vaso-occlusive Pain in Sickle Cell Disease. Paediatr Drugs. 2018 Feb;20(1):29-42. doi: 10.1007/s40272-017-0263-z.
PubMed 28853040Rizio AA, Bhor M, Lin X, McCausland KL, White MK, Paulose J, Nandal S, Halloway RI, Bronte-Hall L. The relationship between frequency and severity of vaso-occlusive crises and health-related quality of life and work productivity in adults with sickle cell disease. Qual Life Res. 2020 Jun;29(6):1533-1547. doi: 10.1007/s11136-019-02412-5. Epub 2020 Jan 13.
PubMed 31933113Okomo U, Meremikwu MM. Fluid replacement therapy for acute episodes of pain in people with sickle cell disease. Cochrane Database Syst Rev. 2015 Mar 12;(3):CD005406. doi: 10.1002/14651858.CD005406.pub4.
PubMed 25764071Brandow AM, Carroll CP, Creary S, Edwards-Elliott R, Glassberg J, Hurley RW, Kutlar A, Seisa M, Stinson J, Strouse JJ, Yusuf F, Zempsky W, Lang E. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Blood Adv. 2020 Jun 23;4(12):2656-2701. doi: 10.1182/bloodadvances.2020001851.
PubMed 32559294Rosa RM, Bierer BE, Thomas R, Stoff JS, Kruskall M, Robinson S, Bunn HF, Epstein FH. A study of induced hyponatremia in the prevention and treatment of sickle-cell crisis. N Engl J Med. 1980 Nov 13;303(20):1138-43. doi: 10.1056/NEJM198011133032002.
PubMed 6999348GBD 2021 Sickle Cell Disease Collaborators. Global, regional, and national prevalence and mortality burden of sickle cell disease, 2000-2021: a systematic analysis from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Aug;10(8):e585-e599. doi: 10.1016/S2352-3026(23)00118-7. Epub 2023 Jun 15.
PubMed 37331373
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)
- ClinicalTrials.gov ID
- NCT07188766
- Acronym / sponsor ID
- FLASC / 2025-01-0451
- Conditions
- SCD, Vaso Occlussive Crisis
- Keywords
- sickle cell disease, sickle cell crisis, intravenous fluid, emergency department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 Sep 2025 (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.
Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain. This study evaluates restrictive versus liberal fluid management strategies in patients with acute VOC.
This multi-center, open-label, non-inferiority RCT will enroll patients with SCD presenting with acute VOC. Participants will be randomized to either a restrictive or liberal intravenous fluid management protocol. Primary outcome is pain score reduction. Secondary outcomes include time to pain resolution, ED length of stay, hospital admission rate, cumulative opioid dose, adverse events (incidence of fluid overload, pulmonary congestion), acute chest syndrome, incidence of acute kidney injury, revisit rates within 72 hours of ED discharge, need for intensive care or high-dependency unit admission, need for additional interventions, and 28 days overall mortality. Data will be analyzed using intention-to-treat principles.
We hypothesize that a restrictive fluid strategy will achieve non-inferior pain control compared to a liberal strategy, while minimizing fluid-related complications. This study will provide evidence to inform clinical guidelines for fluid management in SCD patients experiencing VOCs.
Detailed description
This study is a prospective, non-inferiority, open-label, multicenter randomized-controlled trial (RCT) conducted in the emergency departments (EDs) of tertiary care hospitals in Saudi Arabia. The primary objective is to compare two fluid management strategies- restrictive (intervention) vs. liberal (control) in adult sickle cell disease (SCD) patients hospitalized for VOC. The study evaluates whether a restrictive fluid approach is non-inferior to a liberal strategy in terms of pain resolution, hospitalization duration, and other clinical outcomes.
Patients will be randomized upon ED admission, and their assigned fluid regimen will be administered within the first hour. Clinical teams will monitor outcomes throughout hospitalization or up to 28 days post-enrollment.
Study Population
- Recruitment Screening: All patients admitted to the ED with VOC will be screened for eligibility. Consent Model: A priori informed written consent will be obtained from conscious, coherent patients or substitute decision-makers.
- Inclusion Criteria Age >18 years with confirmed SCD diagnosis. Presenting with VOC requiring hospitalization. Numeric Pain Rating Scale (NPRS) >5 Willingness to participate and provide informed consent.
- Exclusion Criteria Requiring specialized IVF management per the physician's discretion.
Cardiac/Renal Conditions:
Congestive heart failure (CHF) or symptomatic systolic heart failure.
Patients with ESRD on chronic dialysis.
Hemodynamic Instability:
Shock (SBP <100 mmHg or MAP <65) with hypoperfusion signs.
Other Exclusions:
Known/suspected pregnancy.
Prior enrollment in this trial within the last 30 days.
Concurrent enrollment in another trial affecting fluid management.
Inability to obtain IV access.
Trial Intervention
- Screening \& Randomization Screening occurs upon ED admission; evaluations must precede randomization. A screening log will track eligible vs. randomized patients.
- Informed Consent An a priori consent model is used due to the conscious-coherent state of most SCD patients in VOC. Efforts will be made to obtain consent immediately from the patient or surrogate.
- Intervention Arms A. Intervention (Restrictive)Keep-vein-open (KVO) rate only (minimal fluids to maintain IV patency). No additional IV fluids administered.
- Control (Liberal) 20 mL/kg IV bolus (NS or LR over 1 hour) + maintenance fluids (1.5-2 mL/kg/day).
Initiation: Both regimens starts within 1 hour of ED admission and continue until ED discharge.
Hospitalized Patients:
Pain scores (NPRS) recorded at 24, 48, and 72 hours. Total fluid intake documented at hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, non-inferiority, open label multicenter randomized controlled trial. Patients on Intervention Group (Restricted approach group) will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered. Control Group (Liberal Approach Group) Patients will receive an IV bolus of 20 mL/kg of normal saline or lactated Ringer's over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements.
| Arm | Type | Receives |
|---|---|---|
| Restricted approach group | Experimental | Drug: Sodium Chloride (NaCl) 0.9 %Patients in this arm will receive maintenance intravenous fluids at a keep-vein-open (KVO) rate and no extra intravenous fluids is administered |
| Liberal Approach Group | Active comparator | Drug: Sodium Chloride (NaCl) 0.9 %Patients will receive an IV bolus of 20 mL/kg of normal saline or lactated Ringer's over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients >18 years old with a confirmed diagnosis of SCD.
- Presenting with a VOC.
- NPRS >5
- Willingness to participate and provide informed consent.
Key exclusion criteria (8 listed)
- Patient requiring specialized IVF management as per the treating physician discretion.
- Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure
- Patients with ESRD on chronic dialysis
- Patients with signs of shock (low SBP <100 or MAP < 65) and signs of hypo perfusion
- Known or suspected pregnancy
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 |
|---|---|---|
| Sodium Chloride (NaCl) 0.9 %Also: RestrictedKeep vein open rate | Drug | Restricted approach group |
| Sodium Chloride (NaCl) 0.9 %Also: LiberalIV bolus of 20 mL/kg of normal saline over 1 hour, followed by maintenance fluids at 1.5-2 ml/kg times the calculated daily maintenance requirements | Drug | Liberal Approach Group |
Primary outcome
Change in Pain intensity
Time frame: Baseline (within 30 minutes post admission), 1 hour, then hourly until ED discharge or 24- 48- and 72-hours post-admission ( for admitted patients)
Measured using the Numeric Pain Rating Scale (NPRS)
7 secondary outcomes
Time to pain resolution
Time frame: up to 4 hours
ED length of stay
Time frame: at least 4 hours
Hospital admission rate
Time frame: within 24 hours of ED admission
Cumulative Opioid Dose
Time frame: up to 4 hours
Revisit Rates
Time frame: within 72 hours post ED discharge
Overall Mortality
Time frame: within 28 days post-enrollment
Adverse events
Time frame: up to 7 days
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 18 Mar 2026.
- Background: PubMed 28853040Puri L, Nottage KA, Hankins JS, Anghelescu DL. State of the Art Management of Acute Vaso-occlusive Pain in Sickle Cell Disease. Paediatr Drugs. 2018 Feb;20(1):29-42. doi: 10.1007/s40272-017-0263-z.
- Background: PubMed 31933113Rizio AA, Bhor M, Lin X, McCausland KL, White MK, Paulose J, Nandal S, Halloway RI, Bronte-Hall L. The relationship between frequency and severity of vaso-occlusive crises and health-related quality of life and work productivity in adults with sickle cell disease. Qual Life Res. 2020 Jun;29(6):1533-1547. doi: 10.1007/s11136-019-02412-5. Epub 2020 Jan 13.
- Background: PubMed 25764071Okomo U, Meremikwu MM. Fluid replacement therapy for acute episodes of pain in people with sickle cell disease. Cochrane Database Syst Rev. 2015 Mar 12;(3):CD005406. doi: 10.1002/14651858.CD005406.pub4.
- Background: PubMed 32559294Brandow AM, Carroll CP, Creary S, Edwards-Elliott R, Glassberg J, Hurley RW, Kutlar A, Seisa M, Stinson J, Strouse JJ, Yusuf F, Zempsky W, Lang E. American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Blood Adv. 2020 Jun 23;4(12):2656-2701. doi: 10.1182/bloodadvances.2020001851.
- Background: PubMed 6999348Rosa RM, Bierer BE, Thomas R, Stoff JS, Kruskall M, Robinson S, Bunn HF, Epstein FH. A study of induced hyponatremia in the prevention and treatment of sickle-cell crisis. N Engl J Med. 1980 Nov 13;303(20):1138-43. doi: 10.1056/NEJM198011133032002.
- Background: PubMed 37331373GBD 2021 Sickle Cell Disease Collaborators. Global, regional, and national prevalence and mortality burden of sickle cell disease, 2000-2021: a systematic analysis from the Global Burden of Disease Study 2021. Lancet Haematol. 2023 Aug;10(8):e585-e599. doi: 10.1016/S2352-3026(23)00118-7. Epub 2023 Jun 15.
- Individual participant dataSharing planned: Yes. 1. Demographics: Age, sex, and other baseline characteristics. 2. Outcome Measures: primary and secondary outcomes of the trial. 3. Adverse Events: Data on side effects or other adverse events participants experienced during the trial. 4. Treatment Allocations: Information on which participants were assigned to each treatment group.
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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.
Laila Perlas Asonto, RN contact
Mohammed S Alshahrani, MD principal investigator
King Fahd Hospital of the University- Imam Abdulrahman Bin Faisal University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Chloride (NaCl) 0.9 % in people with SCD and Vaso Occlussive Crisis, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
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 4 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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.
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 Mohammed S Alshahrani, MD (+966556966663, msshahrani@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity (time frame: Baseline (within 30 minutes post admission), 1 hour, then hourly until ED discharge or 24- 48- and 72-hours post-admission ( for admitted patients)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07188766, which also lists 6 linked publications.
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 18 Mar 2026.