Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department.

NCT07874919 | Not Yet Recruiting Phase 4

• 1 other identifier: MREC# 3949
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Emergency Department; Procedure sedation; Ketamine; Propofol; Ketofol; Ketadex; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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)

  From initiation of study medication up to 60 minutes after procedure completion

Secondary Outcomes (5)

• Recovery Time

  From procedure completion to achievement of Aldrete score ≥9, assessed up to 60 minutes.

• Incidence of Hemodynamic Adverse Events

  Baseline (pre-sedation) and every 5 minutes up to 60 minutes after procedure completion

• Pain Score

  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

  From initiation of study medication up to 60 minutes after procedure completion.

• Incidence of Nausea and Vomiting

  From procedure completion up to 60 minutes.

Study Arms (2)

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.

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.

Drug: Ketamine (1 mg/kg); Drug: Dexmedetomidine

Interventions

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.

Ketadex; Ketofol

propofol DRUG

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.

Ketofol

Dexmedetomidine DRUG

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.

Ketadex

Normal Saline DRUG

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.

Ketofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital- UMC

Seeb, Muḩāfaz̧at Masqaţ, 123, Oman

Location

MeSH Terms

Conditions

Emergencies

Interventions

Ketamine; Propofol; Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ashraf Fathy Elshehry, FRCEM-UK

  University Medical City / Sultan Qaboos University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf Fathy Elshehry, Fellowship Royal college of Em

CONTACT

0096899896754; elshehry@squ.edu.om

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, treating clinicians, investigators, and outcome assessors will be blinded to treatment allocation. An unblinded study nurse will prepare the study medications according to the randomized allocation. A double-dummy design will be used. Each participant will receive two study syringes: an intravenous bolus syringe and an infusion syringe administered over 10 minutes. The bolus syringe will be covered with an opaque white label to conceal its contents. The unblinded nurse responsible for study drug preparation will not participate in clinical assessment or outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Specialist Emergency Medicine

Study Record Dates

• First Submitted: October 4, 2026
• First Posted: October 15, 2026
• Study Start: October 10, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)