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Esketamine Hydrochloride versus Ketamine Hydrochloride for Procedural Sedation in Adults with Acute Osteoarticular Injuries in the Emergency Department

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

People who have a broken bone or a dislocated joint that needs to be straightened in the emergency department often require procedural sedation so they do not feel pain during the procedure. The condition being studied is Acute osteoarticular injury. In this study two medicines are compared: a newer version called esketamine and the traditional formulation called ketamine. Both drugs are given by intravenous injection, which means the medicine is placed directly into a vein through a small needle.

The purpose of the study is to compare how well patients awaken after the procedure when they receive each medicine. Participants will receive one of the two medicines and will be watched for about an hour after the procedure. Researchers will note how quickly the person wakes up, whether they feel anxious, confused, see things that are not real, have bad dreams, or become restless (agitation). They will also record if extra medication is needed to calm the person, any severe pain after the procedure, and overall satisfaction of both the patient and the medical team. The study follows each participant from the time the medicine is given until they are back to their normal thinking and able to move their hands on command.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Assignment

    After joining the study, you are placed at random into one of two groups. One group receives esketamine and the other group receives ketamine. The assignment is done by the study staff and you do not choose the medication.

  2. Step 2

    Baseline Evaluation

    Study staff measure your vital signs, such as heart rate and blood pressure, and record your body weight. Your weight is needed to calculate the correct dose of the study medication.

  3. Step 3

    Administration of Study Medication

    A single intravenous injection (IV) of the assigned medication is given. If you are in the esketamine group, the dose is 1 mg/kg (one milligram for each kilogram of body weight). If you are in the ketamine group, the dose is 2 mg/kg (two milligrams for each kilogram of body weight). The injection is administered once, at the start of the procedure.

  4. Step 4

    Procedural Sedation

    The medication quickly produces sedation, making you relaxed and less aware of pain. While you are sedated, the medical team performs the required reduction, realignment, or immobilization of the injured limb.

  5. Step 5

    Monitoring During Sedation

    Throughout the sedation, staff continuously watch your breathing, heart rate, and level of consciousness. The level of sedation is measured with the Ramsay score, a scale where higher numbers indicate deeper sedation. Staff also look for any unpleasant effects such as anxiety, confusion, hallucinations, or agitation.

  6. Step 6

    Recovery Observation

    After the procedure, you are observed for at least 60 minutes while you wake up. The quality of awakening is recorded, noting any unpleasant sensations or reactions. If you experience severe agitation, staff may give a rescue medication called midazolam through an IV line, adjusting the dose until you are calm.

  7. Step 7

    Pain Management After Procedure

    If you report pain that you rate as 6 or higher on a scale from 0 (no pain) to 10 (worst possible pain), you may receive opioid analgesia to control the pain.

  8. Step 8

    Satisfaction Assessment

    You will be asked to rate your overall experience on a scale from 0 (minimum satisfaction) to 10 (maximum satisfaction). This rating helps the study understand how you felt about the sedation and recovery.

  9. Step 9

    Discharge

    When you have returned to a stable level of alertness, can follow simple commands, and have acceptable pain control, you are cleared to leave the emergency department.

Who can join the trial?

4 criteria

  • Be at least 18 years old (an adult).
  • Be enrolled in a social security program, which means you have government‑provided health insurance.
  • Be treated by the SMUR (Mobile Emergency and Resuscitation Service) or the SAUV (Critical Emergency Reception Unit) at Nice Hospital, and have an acute osteoarticular injury (a recent bone fracture or joint dislocation) that requires emergency procedural sedation (a short‑term, medically‑controlled sleep) so the injured limb can be reduced (put back in the correct position), realigned (straightened), and immobilized (kept still).
  • Give written informed consent after being told about the study. If severe pain or anxiety makes this impossible at first, a family member or legal representative may give consent, or you may give a verbal agreement now and sign the written form later once you feel better.

Who cannot join the trial?

19 criteria

  • Being currently pregnant or breastfeeding (pregnancy confirmed by a positive beta‑hCG test, which checks for a hormone that shows you are pregnant).
  • Having an allergy to ketamine, esketamine, or any ingredient in esketamine such as hydrochloric acid.
  • Weighing less than 50 kg (about 110 lb) or more than 100 kg (about 220 lb).
  • Having an ASA Physical Status score of 4 or higher (a doctor‑rated scale that indicates very severe overall health problems).
  • Having unstable vital signs, such as:
    • Systolic blood pressure below 90 mmHg or above 180 mmHg (the top number measuring pressure in your arteries).
    • Heart rate below 50 beats per minute or above 150 beats per minute.
    • Breathing rate below 10 breaths per minute or above 30 breaths per minute.
    • Having high blood pressure (hypertension) that is not well controlled with medication.
    • Having a past stroke (a loss of blood flow to the brain) or severe heart failure (the heart cannot pump blood effectively).
    • Having liver problems such as cirrhosis (scarring of the liver) or liver failure.
    • Having visible ischemic heart disease (reduced blood flow to the heart muscle).
    • Having an overactive thyroid (hyperthyroidism) that is not well controlled.
    • Having high pressure inside the skull (intracranial hypertension), eye pressure disease (glaucoma), or an injury to the eye (ocular trauma).
    • Having a history of substance abuse, drug dependence, or a mental health condition called psychosis.
    • Being under the influence of drugs or alcohol with reduced awareness (a Glasgow Coma Scale score less than 15, which measures level of consciousness).
    • Taking certain medicines on a long‑term basis, such as theophylline, aminophylline, methylergometrine, or barbiturates.
    • Being enrolled in another clinical study that could affect the trial medication.
    • Being unable to give free and informed consent, or the emergency enrollment process cannot be used for you.
    • Being an adult who is under legal protection (such as guardianship or curatorship) or who is deprived of liberty.
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Investigated drugs

  • Ketamine

    is a medication that is given through an IV to calm patients and block pain during medical procedures. In this study it is used as the standard treatment (the comparator) to see how well patients recover after the procedure and what side effects may occur.

  • Esketamine

    is a newer version of ketamine that contains only one part (the S‑enantiomer) of the drug. It is also given through an IV to provide sedation for procedures. In the trial it is the test medication, and researchers are looking at whether it helps patients recover more comfortably and with fewer side effects compared with regular ketamine.

What is already known about the treatment

  • Ketamine Hydrochloride

    This medication is given as an intravenous injection and is used to calm patients and relieve pain during emergency procedures such as setting a broken bone. It is a long‑standing drug that is widely accepted in medical practice and has been studied in many clinical reports. Ketamine works by blocking a brain receptor called NMDA, which reduces the feeling of pain and produces a safe, short‑lasting sleep. It belongs to the class of drugs known as dissociative anesthetics.

  • Esketamine Hydrochloride

    This drug is also administered by intravenous injection and is used for procedural sedation in emergency situations like fracture reduction. It is a newer, FDA‑approved form of ketamine that is increasingly described in recent medical literature, especially for depression and procedural sedation. Esketamine blocks the same NMDA receptor as ketamine but does so more strongly, leading to effective sedation at a lower dose. It is classified as a dissociative anesthetic, specifically the S‑enantiomer of ketamine.

Investigated diseases

Acute fracture or joint dislocation - An acute fracture or joint dislocation is a sudden injury that breaks a bone or forces a joint out of its normal position. The injury causes immediate pain, swelling, and loss of normal movement in the affected limb. If the bone fragments or joint surfaces remain misaligned, the body’s repair processes may produce abnormal healing, leading to stiffness or reduced function. Over days to weeks, bone remodeling and soft‑tissue healing gradually restore stability, while the joint may regain alignment through natural tissue contraction. Re‑injury or inadequate reduction can cause the deformity to worsen before healing is complete. The condition typically resolves as the bone and surrounding tissues heal, restoring normal anatomy and function.
Trial detailsLast updated 31 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-527265-30-00Protocol code25-AOI-MED-01Estimated enrolment120 patientsSponsorCentre Hospitalier Universitaire De Nice

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