Failed Moderate Sedation During ProcedureEarly Phase 1NCT03067974
Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
A Early Phase 1 study testing Ketamine Hcl 100Mg/Ml Inj in people with Failed Moderate Sedation During Procedure and Ketamine Adverse Reaction, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Failed Moderate Sedation During Procedure, Ketamine Adverse Reaction
- What is being tested?
- Ketamine Hcl 100Mg/Ml Inj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 22 Jan 2019
- Phase
- Early Phase 1
- 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus
- Body weight of 20kg or less (actual, estimated, or measured)
- NPO for four hours or more
- Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.
Who cannot join
- Discretion of parents
- Discretion of provider
- Body weight greater than 20kg (actual, estimated, or measured)
- Starting Aldrete score <9/10
- Known or suspected psychosis
- Known or suspected central nervous system mass, abnormalities, hydrocephalus, or other condition that would suggest elevated pre-anesthetic cerebrospinal fluid pressure
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- Significant elevation in blood pressure
- Known hypersensitivity to ketamine
- Non-English or Spanish speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner Univsersity Medical Center Tucson
Tucson, Arizona, 85719
About this study
The purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.
- Being tested
- Ketamine Hcl 100Mg/Ml Inj
- Keywords
- ketamine, pediatric, procedural sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Hcl 100Mg/Ml InjDrug
10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation
| Study group | Role | What they receive |
|---|---|---|
| Intranasal ketamine arm | Experimental | 10mg/kg intranasal ketamine administered one time Receives: Drug: Ketamine Hcl 100Mg/Ml Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful procedural sedation
Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.
Measured: The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start21 Sep 2017
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Why it stopped: Initial results did not show benefit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Moderate Sedation During ProcedureStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Children who meet inclusion and exclusion criteria will be approached for participation in the study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivienne Ng, University of Arizona
- Investigators
- Vivienne Ng, MD, MPH, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067974
- Sponsor's protocol ID
- 1705414419
- Status last verified
- Jan 2019
- First submitted
- 11 Feb 2017
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine for Pediatric Procedural Sedation: a Feasibility Study
- ClinicalTrials.gov ID
- NCT03067974
- Acronym / sponsor ID
- 1705414419
- Keywords
- ketamine, pediatric, procedural sedation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Initial results did not show benefit.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 1 Mar 2017 (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 purpose of this study is to evaluate the feasibility of intranasal ketamine for adequate sedation of children undergoing minor procedures in the Emergency Department. An intranasal dose of 10mg/kg will be used in patients requiring procedural sedation. The investigators hypothesize that this dose of intranasal ketamine will be able to provide adequate sedation and analgesia for the physician to successfully complete the planned diagnostic or therapeutic intervention (Pediatr Emer Care 2012;28: 767-70). The primary endpoint will be successful sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children who meet inclusion and exclusion criteria will be approached for participation in the study.
| Arm | Type | Receives |
|---|---|---|
| Intranasal ketamine arm | Experimental | Drug: Ketamine Hcl 100Mg/Ml Inj10mg/kg intranasal ketamine administered one time |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ages 2 years to 7 years who present as patients to the Pediatric Emergency Department at Banner University Medical Center Tucson Campus
- Body weight of 20kg or less (actual, estimated, or measured)
- NPO for four hours or more
- Undergoing various procedures, which are deemed by the treating provider to require procedural sedation for the completion of the procedure.
Key exclusion criteria (9 listed)
- Discretion of parents
- Discretion of provider
- Body weight greater than 20kg (actual, estimated, or measured)
- Starting Aldrete score <9/10
- Known or suspected psychosis
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 |
|---|---|---|
| Ketamine Hcl 100Mg/Ml Inj10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation | Drug | Intranasal ketamine arm |
Primary outcome
Successful procedural sedation
Time frame: The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior).
Successful procedural sedation, as defined by the ability to complete the planned procedure without rescue medication, which includes re-dosing of the same medication.
Results and safety
The study was stopped early (reason given: Initial results did not show benefit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No
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.
Vivienne Ng, MD, MPH principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ketamine Hcl 100Mg/Ml Inj in people with Failed Moderate Sedation During Procedure and Ketamine Adverse Reaction, run by University of Arizona at 1 site in United States.
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 9 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: stopped early, as of the sponsor's last update on 28 Jan 2019. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Initial results did not show benefit.). Results are not available in the source record.
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?
Successful procedural sedation (time frame: The patient will be assessed from the start of procedural sedation medication administration until the completion of the procedural sedation, defined as the patient retuning to baseline (alert and oriented x3 with normal behavior).). 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 28 Jan 2019; AzTrials last refreshed its copy on 1 Nov 2026.