PainNCT02648412
Pupillary Dilation After Incremental Tetanic Stimulations Under Ketamine Sedation
A study testing ketamine and Tetanic stimulations of incremental intensities in people with Pain and Anesthesia, run by Pr Isabelle CONSTANT at 1 site in France.
Trial summary
The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pain, Anesthesia
- What is being tested?
- ketamine and Tetanic stimulations of incremental intensities
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient admitted to pediatric burns care unit
- Burnt skin area 5-40%
- Scheduled for a dressing change under ketamine sedation
Who cannot join
- Neurologic or ophthalmic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation
The aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation.
After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.
- Conditions
- Pain, Anesthesia
- Being tested
- ketamine, Tetanic stimulations of incremental intensities
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
bolus 1 mg/kg
Tetanic stimulations of incremental intensitiesProcedure or surgery
10-20-30-40-60 milliamps on the patient's left forearm
| Study group | Role | What they receive |
|---|---|---|
| Ketamine sedation | Experimental | Procedure scheduled under ketamine sedation. Baseline pupillary diameter measurement in alert subjects. Injection of a bolus of 1 mg/kg of ketamine. Every minute, tetanic stimulations of incremental intensities (10-20-30-40-60 milliamps), during 5 seconds.
Pupillary diameter measurement before and after each stimulation. End of study period, beginning of procedure. Receives: Drug: ketamine; Procedure: Tetanic stimulations of incremental intensities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry
Non-invasive measurement of pupillary diameter using an infrared camera, for each of the 6 stimulations per patient
Measured: 30 seconds after each stimulation (6 stimulations per patient)
Secondary outcomes (1)
Heart rate variation
Measured: 30 seconds after each stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr Isabelle CONSTANT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr Isabelle CONSTANT, Hôpital Armand Trousseau
- Investigators
- Isabelle Constant, PHD, Study director, University Hospital Armand Trousseau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648412
- Sponsor's protocol ID
- Pupillo ketamine
- Status last verified
- Dec 2016
- First submitted
- 4 Jan 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillary Diameter Variation After Standardized Tetanic Stimulations of Incremental Intensities in Patients Under Ketamine Sedation
- ClinicalTrials.gov ID
- NCT02648412
- Acronym / sponsor ID
- Pupillo ketamine
- Conditions
- Pain, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pr Isabelle CONSTANTUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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 aim of the study was to describe the relationship between the intensity of a standardized tetanic stimulation and the associated reflex pupillary dilation in patients under ketamine sedation.
After an intravenous bolus of 1 mg/kg of ketamine, tetanic stimulations were performed every minute at increasing intensities of 10, 20, 30, 40 and 60 milliamps (similar to the stimulations of neuromuscular blocking agents monitoring). Pupillary diameter was measured before and after each stimulation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine sedation | Experimental | Drug: ketamine, Procedure: Tetanic stimulations of incremental intensitiesProcedure scheduled under ketamine sedation. Baseline pupillary diameter measurement in alert subjects. Injection of a bolus of 1 mg/kg of ketamine. Every minute, tetanic stimulations of incremental intensities (10-20-30-40-60 milliamps), during 5 seconds. Pupillary diameter measurement before and after each stimulation. End of study period, beginning of procedure. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient admitted to pediatric burns care unit
- Burnt skin area 5-40%
- Scheduled for a dressing change under ketamine sedation
Key exclusion criteria (1 listed)
- Neurologic or ophthalmic disease
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 |
|---|---|---|
| ketaminebolus 1 mg/kg | Drug | Ketamine sedation |
| Tetanic stimulations of incremental intensities10-20-30-40-60 milliamps on the patient's left forearm | Procedure or surgery | Ketamine sedation |
Primary outcome
Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry
Time frame: 30 seconds after each stimulation (6 stimulations per patient)
Non-invasive measurement of pupillary diameter using an infrared camera, for each of the 6 stimulations per patient
1 secondary outcome
Heart rate variation
Time frame: 30 seconds after each stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
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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. This study is not recruiting at the moment.
Isabelle Constant, PHD study director
University Hospital Armand Trousseau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketamine and Tetanic stimulations of incremental intensities in people with Pain and Anesthesia, run by Pr Isabelle CONSTANT at 1 site in France.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 22 Dec 2016. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillary dilation: difference between post- and pre-stimulation pupillary diameter assessed by videopupillometry (time frame: 30 seconds after each stimulation (6 stimulations per patient)). 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 22 Dec 2016.