Procedural PainNCT07916064
Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural Analgesia
An observational study of Procedural Pain and Procedural Sedation and Analgesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn whether ketamine given for procedural analgesia changes intracranial pressure in adult emergency department patients. Intracranial pressure is assessed non-invasively by measuring optic nerve sheath diameter (ONSD) with bedside ultrasonography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Pain, Procedural Sedation and Analgesia, Intracranial Pressure
- What is being tested?
- ketamine
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged 18 years or older) presenting to the Emergency Department of Ankara Etlik City Hospital who receive intravenous ketamine for procedural analgesia as part of routine care.
Who may be able to join
- Age 18 years or older
- Hemodynamically stable
- Receiving intravenous ketamine for procedural analgesia for any clinical indication
- Written and verbal informed consent
Who cannot join
- Pregnancy or suspected pregnancy
- History of moderate or severe head trauma
- History of cerebrovascular disease
- Intracranial mass
- Previous intracranial surgery
- Signs of increased intracranial pressure
Show all 20Show fewer
- Chronic obstructive pulmonary disease
- Hypercapnia
- Porphyria
- Liver failure
- Chronic kidney disease
- Cerebral palsy
- Multiple sclerosis
- Use of antidepressant medication
- Optic neuritis
- Globe rupture
- Glaucoma
- Use of an agent other than ketamine for procedural analgesia
- Known allergy or intolerance to ketamine
- Disorientation, inability to cooperate, or inability to communicate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Etlik, 06170
Aylin Topçu Genç, +90 546 581 0996, aylintopcun@gmail.com
Ömer Faruk Turan, MD, Assoc. Prof.
About this study
Official title: Effect of Ketamine for Procedural Analgesia on Intracranial Pressure: A Prospective Assessment Using Optic Nerve Sheath Diameter
The goal of this observational study is to learn whether ketamine given for procedural analgesia changes intracranial pressure in adult emergency department patients. Intracranial pressure is assessed non-invasively by measuring optic nerve sheath diameter (ONSD) with bedside ultrasonography. The main questions it aims to answer are:
- Does ONSD change after ketamine administration compared with the measurement taken before ketamine?
- Does the change in ONSD differ between patients receiving 0.5 mg/kg and 1 mg/kg ketamine? Participants who receive intravenous ketamine as part of their routine emergency care will have ONSD, vital signs, and pain scores recorded before ketamine administration and at 2, 5, 15, and 30 minutes after administration.
Read the detailed description
This prospective observational study is conducted in the Emergency Department of Ankara Etlik City Hospital. Adult patients who receive intravenous ketamine for procedural analgesia are enrolled consecutively after written and verbal informed consent. The decision to use ketamine and the dose (0.5 mg/kg or 1 mg/kg) are made by the treating emergency physician as part of routine care; the study does not assign, change, or interfere with any treatment. Patients are grouped according to the ketamine dose they receive.
Optic nerve sheath diameter (ONSD) is measured with bedside ocular ultrasonography immediately before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration. Systolic and diastolic blood pressure, heart rate, oxygen saturation, body temperature, and pain intensity (Numeric Rating Scale) are recorded at the same time points. Adverse events related to ketamine are recorded during the 30-minute observation period. Ocular ultrasonography is the only study-specific procedure; it is non-invasive and painless. The planned sample size is 160 patients.
- Being tested
- ketamine
- Keywords
- ketamine, optic nerve sheath diameter, ocular ultrasonography, point-of-care ultrasound, emergency department
- Medical subject headings
- Pain, Procedural, Agnosia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
Also called ketalar, Ketamine hydrochloride
Intravenous ketamine given for procedural analgesia as part of routine emergency care. The dose (0.5 mg/kg or 1 mg/kg) is chosen by the treating physician; the study does not assign or modify treatment.
| Study group | Role | What they receive |
|---|---|---|
| "Ketamine 0.5 mg/kg | Adult emergency department patients who receive intravenous ketamine 0.5 mg/kg for procedural analgesia, with the dose chosen by the treating physician as part of routine care. Receives: Drug: ketamine | |
| Ketamine 1 mg/kg | Adult emergency department patients who receive intravenous ketamine 1 mg/kg for procedural analgesia, with the dose chosen by the treating physician as part of routine care. Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optic Nerve Sheath Diameter From Baseline
Optic nerve sheath diameter (ONSD, mm) measured by bedside ocular ultrasonography as a non-invasive indicator of intracranial pressure. Change from the pre-ketamine measurement (minute 0) is assessed at each time point after ketamine administration.
Measured: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Secondary outcomes (7)
Change in Optic Nerve Sheath Diameter by Ketamine Dose
Change in ONSD (mm) from minute 0, compared between patients receiving 0.5 mg/kg and 1 mg/kg ketamine.
Measured: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Systolic Blood Pressure
Systolic blood pressure (mmHg) measured non-invasively.
Measured: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Diastolic Blood Pressure
Diastolic blood pressure (mmHg) measured non-invasively.
Measured: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
"Change in Heart Rate
Heart rate (beats per minute).
Measured: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Oxygen Saturation
Peripheral oxygen saturation (%) measured by pulse oximetry.
Measured: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Pain Intensity
Pain intensity measured with the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate more severe pain.
Measured: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Number of Participants With Ketamine-Related Adverse Events
Adverse events attributed to ketamine, observed and recorded by the investigators.
Measured: From ketamine administration to 30 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Dec 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ömer Faruk Turan, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916064
- Sponsor's protocol ID
- AESH-EK-2025-325
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. In accordance with the ethics committee approval, study data are accessible only to the study investigators
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketamine for Procedural Analgesia on Intracranial Pressure: A Prospective Assessment Using Optic Nerve Sheath Diameter
- ClinicalTrials.gov ID
- NCT07916064
- Acronym / sponsor ID
- AESH-EK-2025-325
- Keywords
- ketamine, optic nerve sheath diameter, ocular ultrasonography, point-of-care ultrasound, emergency department
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 4 Nov 2026 (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 goal of this observational study is to learn whether ketamine given for procedural analgesia changes intracranial pressure in adult emergency department patients. Intracranial pressure is assessed non-invasively by measuring optic nerve sheath diameter (ONSD) with bedside ultrasonography. The main questions it aims to answer are:
- Does ONSD change after ketamine administration compared with the measurement taken before ketamine?
- Does the change in ONSD differ between patients receiving 0.5 mg/kg and 1 mg/kg ketamine? Participants who receive intravenous ketamine as part of their routine emergency care will have ONSD, vital signs, and pain scores recorded before ketamine administration and at 2, 5, 15, and 30 minutes after administration.
Detailed description
This prospective observational study is conducted in the Emergency Department of Ankara Etlik City Hospital. Adult patients who receive intravenous ketamine for procedural analgesia are enrolled consecutively after written and verbal informed consent. The decision to use ketamine and the dose (0.5 mg/kg or 1 mg/kg) are made by the treating emergency physician as part of routine care; the study does not assign, change, or interfere with any treatment. Patients are grouped according to the ketamine dose they receive.
Optic nerve sheath diameter (ONSD) is measured with bedside ocular ultrasonography immediately before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration. Systolic and diastolic blood pressure, heart rate, oxygen saturation, body temperature, and pain intensity (Numeric Rating Scale) are recorded at the same time points. Adverse events related to ketamine are recorded during the 30-minute observation period. Ocular ultrasonography is the only study-specific procedure; it is non-invasive and painless. The planned sample size is 160 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Ketamine 0.5 mg/kg | – | Drug: ketamineAdult emergency department patients who receive intravenous ketamine 0.5 mg/kg for procedural analgesia, with the dose chosen by the treating physician as part of routine care. |
| Ketamine 1 mg/kg | – | Drug: ketamineAdult emergency department patients who receive intravenous ketamine 1 mg/kg for procedural analgesia, with the dose chosen by the treating physician as part of routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged 18 years or older) presenting to the Emergency Department of Ankara Etlik City Hospital who receive intravenous ketamine for procedural analgesia as part of routine care.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Hemodynamically stable
- Receiving intravenous ketamine for procedural analgesia for any clinical indication
- Written and verbal informed consent
Key exclusion criteria (20 listed)
- Pregnancy or suspected pregnancy
- History of moderate or severe head trauma
- History of cerebrovascular disease
- Intracranial mass
- Previous intracranial surgery
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 |
|---|---|---|
| ketamineAlso: ketalar, Ketamine hydrochlorideIntravenous ketamine given for procedural analgesia as part of routine emergency care. The dose (0.5 mg/kg or 1 mg/kg) is chosen by the treating physician; the study does not assign or modify treatment. | Drug | "Ketamine 0.5 mg/kg, Ketamine 1 mg/kg |
Primary outcome
Change in Optic Nerve Sheath Diameter From Baseline
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Optic nerve sheath diameter (ONSD, mm) measured by bedside ocular ultrasonography as a non-invasive indicator of intracranial pressure. Change from the pre-ketamine measurement (minute 0) is assessed at each time point after ketamine administration.
7 secondary outcomes
Change in Optic Nerve Sheath Diameter by Ketamine Dose
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Systolic Blood Pressure
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Diastolic Blood Pressure
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
"Change in Heart Rate
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Oxygen Saturation
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Change in Pain Intensity
Time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration
Number of Participants With Ketamine-Related Adverse Events
Time frame: From ketamine administration to 30 minutes after administration
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. In accordance with the ethics committee approval, study data are accessible only to the study investigators
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedural Pain and Procedural Sedation and Analgesia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 20 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 4 Nov 2026. 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Optic Nerve Sheath Diameter From Baseline (time frame: Before ketamine administration (minute 0) and at 2, 5, 15, and 30 minutes after administration). 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 4 Nov 2026.