Procedural SedationPhase 4NCT07874919
Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department.
A Phase 4 study testing Ketamine (1 mg/kg), propofol and Dexmedetomidine in people with Procedural Sedation, run by Sultan Qaboos University at 1 site in Oman.
Trial summary
This randomized controlled trial will compare two medication combinations, ketamine-dexmedetomidine (Ketadex) and ketamine-propofol (Ketofol), for procedural sedation in adults undergoing painful procedures in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Ketamine (1 mg/kg), propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteOman
- Study dates
- 10 Oct 2026to 1 Mar 2029
- Phase
- Phase 4
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Requiring procedural sedation for a diagnostic or therapeutic procedure in the Emergency Department.
- ASA class I-II, or stable ASA class III at the treating physician's discretion.
- Procedure anticipated to last <30 minutes.
- Able to provide informed consent.
Who cannot join
- Known allergy or hypersensitivity to propofol, egg/soy, ketamine, or dexmedetomidine.
- Hemodynamic instability (systolic blood pressure <90 mmHg before sedation).
- Severe coronary artery disease or cardiomyopathy.
- Severe asthma or COPD with acute decompensation.
- Baseline hypoxia or requirement for ventilatory support.
- Pregnancy.
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- Intracranial hypertension or glaucoma.
- Active psychosis or hallucinations.
- Current use of significant beta-blockers or clonidine.
- Administration of sedative or opioid medication before enrollment that, in the clinician's judgment, is likely to have a clinically significant residual effect at the time of procedural sedation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site
Sultan Qaboos University Hospital- UMC
Seeb, Muḩāfaz̧at Masqaţ, 123
Ashraf Fathy Elshehry, FRCEM-UK, 0096899896754, elshehry@squ.edu.om
About this study
Official title: Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department: A Randomized Controlled Trial
This randomized controlled trial will compare two medication combinations, ketamine-dexmedetomidine (Ketadex) and ketamine-propofol (Ketofol), for procedural sedation in adults undergoing painful procedures in the emergency department. The primary objective is to compare the respiratory safety of the two sedation regimens, particularly the occurrence of hypoxic events and the need for airway interventions. Participants will be randomly assigned to receive either Ketadex or Ketofol. The study will also compare recovery time, hemodynamic effects, pain, emergence reactions, nausea and vomiting, and other adverse events between the two groups. The study will be conducted in the Emergency Department at Sultan Qaboos University Hospital, University Medical City, Oman.
- Conditions
- Procedural Sedation
- Being tested
- Ketamine (1 mg/kg), propofol, Dexmedetomidine, Normal Saline
- Keywords
- Emergency Department, Procedure sedation, Ketamine, Propofol, Ketofol, Ketadex, Dexmedetomidine
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (1 mg/kg)Drug
Ketamine 1 mg/kg will be administered intravenously as a bolus. In the Ketofol arm, ketamine will be mixed with propofol 1 mg/kg in the same syringe. In the Ketadex arm, ketamine 1 mg/kg will be administered without propofol in the bolus syringe. The bolus syringe will be covered with an opaque white label to maintain blinding.
propofolDrug
Propofol 1 mg/kg will be mixed with ketamine 1 mg/kg in the same syringe and administered as an intravenous bolus to participants assigned to the Ketofol arm. The syringe will be covered with an opaque white label to maintain blinding.
DexmedetomidineDrug
Dexmedetomidine 1 microgram/kg will be administered intravenously over 10 minutes using an infusion pump or syringe driver to participants assigned to the Ketadex arm.
Normal SalineDrug
Normal saline, 15 mL, will be administered intravenously over 10 minutes using an infusion pump or syringe driver to participants assigned to the Ketofol arm. It will serve as the placebo infusion in the double-dummy design.
| Study group | Role | What they receive |
|---|---|---|
| Ketofol | Experimental | Participants randomized to the Ketofol arm will receive ketamine 1 mg/kg plus propofol 1 mg/kg as an intravenous bolus, followed by 15 mL of normal saline placebo administered intravenously over 10 minutes. Receives: Drug: Ketamine (1 mg/kg); Drug: propofol; Drug: Normal Saline |
| Ketadex | Experimental | Participants randomized to the Ketadex arm will receive ketamine 1 mg/kg as an intravenous bolus, followed by dexmedetomidine 1 microgram/kg administered intravenously over 10 minutes. Receives: Drug: Ketamine (1 mg/kg); Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Respiratory Adverse Events
Incidence of respiratory adverse events, defined as oxygen desaturation (SpO₂ <94% for >15 seconds) and/or requirement for airway intervention (jaw thrust, bag-valve-mask ventilation, or intubation)
Measured: From initiation of study medication up to 60 minutes after procedure completion
Secondary outcomes (5)
Recovery Time
Time in minutes from the end of the procedure to achievement of an Aldrete recovery score ≥9.
Measured: From procedure completion to achievement of Aldrete score ≥9, assessed up to 60 minutes.
Incidence of Hemodynamic Adverse Events
Effects: Changes in blood pressure and heart rate from baseline, including incidence of hypotension (SBP <90 mmHg or >20% decrease from baseline), bradycardia (HR <50 bpm), and tachycardia (HR >120 bpm).
Measured: Baseline (pre-sedation) and every 5 minutes up to 60 minutes after procedure completion
Pain Score
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain) upon achieving an Aldrete recovery score ≥9 and 30 minutes after procedure completion. We will also record the administration of additional rescue analgesic medication during the post-procedure observation period.
Measured: At achievement of an Aldrete recovery score ≥9 (within 60 minutes after procedure completion) and at 30 minutes after procedure completion.
Incidence of Emergence Reactions
Incidence of emergence reactions following procedural sedation, including agitation, hallucinations, confusion, or other behavioral disturbances occurring during emergence from sedation. We will record and compare the proportion of participants experiencing at least one emergence reaction between the two study groups.
Measured: From initiation of study medication up to 60 minutes after procedure completion.
Incidence of Nausea and Vomiting
Incidence of nausea and/or vomiting occurring following administration of the study medications.
Measured: From procedure completion up to 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ashraf Elshehry, Sultan Qaboos University
- Investigators
- Ashraf Fathy Elshehry, FRCEM-UK, Principal investigator, University Medical City / Sultan Qaboos University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874919
- Sponsor's protocol ID
- MREC# 3949
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data with researchers outside the study team. Study findings will be disseminated in aggregate form through scientific presentations and publications.