TraumaPhase 4NCT03781817
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
A Phase 4 study testing Intravenous Ketamine and Intranasal Ketamine in people with Trauma and Fractures, Closed, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Trauma, Fractures, Closed, Children, Only
- What is being tested?
- Intravenous Ketamine and Intranasal Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 30 Apr 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children 1-18 years of age.
- American Society of Anesthesiologists (ASA) I or II
- Non-operative fracture requiring reduction
- Body weight less than or equal to 25 kg as measured by standard weighing scale
Who cannot join
- ASA classification III or above
- Age less than 1 year
- History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder
- Prior allergy to ketamine
- Unavailable parent or guardian to provide consent
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.
Read the detailed description
The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups.
- Conditions
- Trauma, Fractures, Closed, Children, Only, Deep Sedation, Ketamine
- Being tested
- Intravenous Ketamine, Intranasal Ketamine
- Keywords
- procedural sedation, ketamine, pediatric, fracture, intranasal, intravenous, emergency department
- Medical subject headings
- Wounds and Injuries, Fractures, Closed, Fractures, Bone, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous KetamineDrug
Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
Intranasal KetamineDrug
Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous ketamine | Active comparator | Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline. Receives: Drug: Intravenous Ketamine |
| Intranasal ketamine | Experimental | Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline. Receives: Drug: Intranasal Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved Adequate Sedation.
Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
Measured: Induction up to 10 minutes
Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications.
Measured: From induction to discharge from sedation by emergency physician, up to 3 hours.
Secondary outcomes (3)
Percentage of Participants With Non-serious Adverse Events.
Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
Measured: From induction to discharge from the emergency department.
Duration of Sedation Using Modified Ramsay Sedation Scale.
Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 2 or less is set to be satisfactory for discharge from sedation.
Measured: From induction to discharge from sedation by the emergency physician.
Duration of Emergency Department Stay.
Measured from time of arrival to emergency department to discharge order.
Measured: From arrival to emergency department to discharge order entered by emergency physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start9 Sep 2019
- Primary completion21 Jan 2022
- Study completion30 Apr 2022
Why it stopped: Transition/change of primary investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Statler, University of Alabama at Birmingham
- Investigators
- James Statler, MD, Study chair, Emory UniversityJudson Barber, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781817
- Sponsor's protocol ID
- IRB-300002731
- Status last verified
- Apr 2023
- First submitted
- 18 Dec 2018
- Last updated
- 20 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures
- ClinicalTrials.gov ID
- NCT03781817
- Acronym / sponsor ID
- IRB-300002731
- Conditions
- Trauma, Fractures, Closed, Children, Only, Deep Sedation, Ketamine
- Keywords
- procedural sedation, ketamine, pediatric, fracture, intranasal, intravenous, emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Transition/change of primary investigators
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 20 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a randomized clinical trial involving children with non-operative fractures presenting the emergency department randomized either to intranasal or intravenous ketamine.
Detailed description
The purpose of this study is to determine if Intranasal Ketamine (INK) is efficacious for Procedural Sedation and Analgesia (PSA) when compared to Intravenous Ketamine (IVK) in children with non-operative fractures. The primary aim is to determine if INK provides non-inferior sedation to IVK as defined by a Modified Ramsay Sedation score of ≥ 4 and also to compare the proportion of successful procedure between two treatment groups. The secondary aim is to compare proportion of adverse events and compare duration of sedation and length of emergency department (ED) stay between treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous ketamine | Active comparator | Drug: Intravenous KetamineParticipants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline. |
| Intranasal ketamine | Experimental | Drug: Intranasal KetamineParticipants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children 1-18 years of age.
- American Society of Anesthesiologists (ASA) I or II
- Non-operative fracture requiring reduction
- Body weight less than or equal to 25 kg as measured by standard weighing scale
Key exclusion criteria (6 listed)
- ASA classification III or above
- Age less than 1 year
- History of hypertension, known coronary artery disease or Kawasaki disease, congestive heart failure, acute glaucoma or globe injury, increased intracranial pressure or intracranial mass lesion, acute porphyria, developmental delays, or major psychiatric disorder
- Prior allergy to ketamine
- Unavailable parent or guardian to provide consent
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 |
|---|---|---|
| Intravenous KetamineSubject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. | Drug | Intravenous ketamine |
| Intranasal KetamineSubject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved. | Drug | Intranasal ketamine |
Primary outcome
Number of Participants Who Achieved Adequate Sedation.
Time frame: Induction up to 10 minutes
Determine if IN ketamine provides non-inferior sedation to IV ketamine as defined by a Modified Ramsay Sedation score of ≥ 4. Modified Ramsay Sedation scale is used to evaluate levels of sedation. The scale range is from 0 to 6 with a higher score indicated deeper levels of sedation. At levels of 4 or greater is set to be satisfactory for deep sedation.
Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
Time frame: From induction to discharge from sedation by emergency physician, up to 3 hours.
Rescue medication is defined as requiring additional doses of Ketamine to maintain adequate sedation. Successful procedure completion will be define as completing the procedure with only the induction dose and without requiring rescue medications.
3 secondary outcomes
Percentage of Participants With Non-serious Adverse Events.
Time frame: From induction to discharge from the emergency department.
Duration of Sedation Using Modified Ramsay Sedation Scale.
Time frame: From induction to discharge from sedation by the emergency physician.
Duration of Emergency Department Stay.
Time frame: From arrival to emergency department to discharge order entered by emergency physician.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
James Statler, MD study chair
Emory University
Judson Barber, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Ketamine and Intranasal Ketamine in people with Trauma and Fractures, Closed, run by University of Alabama at Birmingham 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 6 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 20 Apr 2023. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Achieved Adequate Sedation. (time frame: Induction up to 10 minutes). The study lists 2 primary outcomes in all. 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 20 Apr 2023.