AnxietyPhase 4NCT03043430
Intranasal Ketamine for Anxiolysis in Pediatric Emergency Department Patients
A Phase 4 study testing Ketamine 100 MG/ML and Midazolam 5 MG/ML in people with Anxiety and Pediatric ALL, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric patients requiring minor procedures in the Emergency Department setting. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Anxiety, Pediatric ALL, Procedural Anxiety
- What is being tested?
- Ketamine 100 MG/ML and Midazolam 5 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Apr 2023
- Phase
- Phase 4
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients age 2 to 12 years who present to the ED
- Requiring intravenous access
- Requiring laceration repairs
- Requiring incision and drainage of abscesses
- Requiring digital nerve blocks
- Requiring radiological imaging
- Requiring bladder catheterization
- Requiring foreign body removal.
Who cannot join
- Vital sign abnormalities greater than 20% deviation from age-normalized ranges
- Altered mental status/delirium or intoxication
- Patient or patient's parent/guardian are unwilling to participate or provide informed consent
- Any allergy to ketamine or midazolam
- Patient is female with history of menarche
- Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
Show all 17Show fewer
- Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
- Presence of intracranial mass or vascular lesion.
- Presence of a history of psychosis or hallucinations
- Weight greater than 100kg
- History of increased intracranial pressure/ hypertensive hydrocephalus within the last 3 months
- Non-English speaking/reading parent/guardian and/or patients
- Patient is acutely psychotic
- Provider feels that patient currently or likely will require chemical and/or physical restraints
- History of prolonged QT-interval
- Nasal trauma
- Epistaxis
Trial locations and contacts
1 site in 1 country.
United States1 site
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial
Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric patients requiring minor procedures in the Emergency Department setting. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale Preoperative Anxiety Scale (mYPAS).
Read the detailed description
The intranasal route of drug delivery is commonly used in Emergency Departments (ED) in pediatric patients. Multiple trials have shown the safety of administration of intranasal ketamine, including studies performed in the ED to treat pain in pediatric patients. The use of ketamine for anxiolysis has not been directly studied; however, ketamine has been shown to have anxiolytic effect at low doses as secondary outcomes when studied. Midazolam has been established as an effective medication to provide analgesia and anxiolysis. Investigators plan to conduct a randomized, double-blinded, controlled study in the Emergency Department. Pediatric patients presenting to the ED with the need for minor procedures who meet the inclusion and exclusion criteria will be consented, and if amenable, will be enrolled. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). Patients will be tracked for symptom improvement within the Emergency Department. The primary outcome will be change in anxiety from initial measurement to measurement 5 minutes pre-procedure using the Modified Yale Preoperative Anxiety Scale (mYPAS). Secondary outcomes will include sedation level, adverse events, need for additional medications, change in pain rating, patient and/or parent/guardian satisfaction.
- Conditions
- Anxiety, Pediatric ALL, Procedural Anxiety
- Being tested
- Ketamine 100 MG/ML, Midazolam 5 MG/ML
- Medical subject headings
- Anxiety Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 100 MG/MLDrug
Administer ketamine via mucosal atomization device
Midazolam 5 MG/MLDrug
Administer midazolam via mucosal atomization device
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Ketamine 100 mg/mL concentration administered in a single 1.0 mg/kg dose with a maximum of 50mg intranasal via mucosal atomization device. Receives: Drug: Ketamine 100 MG/ML |
| Midazolam | Active comparator | Midazolam 5 mg/mL concentration administered in a single administered in a single 0.3 mg/kg dose with a maximum of 5mg intranasal via mucosal atomization device. Receives: Drug: Midazolam 5 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mYPAS
Modified Yale preoperative anxiety scale
Measured: Change in score between initial measurement versus 5 minutes pre-procedure
Secondary outcomes (3)
Change in sedation scale
University of Michigan sedation scale
Measured: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
Change in pain rating (Wong-Baker Pain Faces Rating Scale)
Wong-Baker Pain Faces Rating Scale
Measured: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
Change in anxiety score (Visual analogue scale)
Visual analogue scale
Measured: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study startMay 2016
- Primary completionApr 2023
- Study completionApr 2023
Why it stopped: Research manpower shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of two treatment arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael D. April, Brooke Army Medical Center
- Investigators
- Nadia M Pearson, MD, Principal investigator, Faculty Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043430
- Sponsor's protocol ID
- C.2016.021
- Status last verified
- Apr 2023
- First submitted
- 30 Jan 2017
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hosseini Jahromi SA, Hosseini Valami SM, Adeli N, Yazdi Z. Comparison of the effects of intranasal midazolam versus different doses of intranasal ketamine on reducing preoperative pediatric anxiety: a prospective randomized clinical trial. J Anesth. 2012 Dec;26(6):878-82. doi: 10.1007/s00540-012-1422-6. Epub 2012 Jun 12.
PubMed 22688444Roelofse JA, Shipton EA, de la Harpe CJ, Blignaut RJ. Intranasal sufentanil/midazolam versus ketamine/midazolam for analgesia/sedation in the pediatric population prior to undergoing multiple dental extractions under general anesthesia: a prospective, double-blind, randomized comparison. Anesth Prog. 2004;51(4):114-21.
PubMed 15675259Narendra PL, Naphade RW, Nallamilli S, Mohd S. A comparison of intranasal ketamine and intranasal midazolam for pediatric premedication. Anesth Essays Res. 2015 May-Aug;9(2):213-8. doi: 10.4103/0259-1162.154051.
PubMed 26417129Khatavkar SS, Bakhshi RG. Comparison of nasal Midazolam with Ketamine versus nasal Midazolam as a premedication in children. Saudi J Anaesth. 2014 Jan;8(1):17-21. doi: 10.4103/1658-354X.125904.
PubMed 24665234
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiolysis for Emergency Department Procedures in Pediatric Patients Using Intranasal Ketamine Compared With Intranasal Midazolam: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03043430
- Acronym / sponsor ID
- C.2016.021
- Conditions
- Anxiety, Pediatric ALL, Procedural Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Research manpower shortage
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- May 2016 (actual)
- Primary completion
- Apr 2023 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 6 Feb 2017 (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.
Investigators plan to conduct a randomized, double-blinded, controlled study among pediatric patients requiring minor procedures in the Emergency Department setting. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). The primary outcome will be change in anxiety using the Modified Yale Preoperative Anxiety Scale (mYPAS).
Detailed description
The intranasal route of drug delivery is commonly used in Emergency Departments (ED) in pediatric patients. Multiple trials have shown the safety of administration of intranasal ketamine, including studies performed in the ED to treat pain in pediatric patients. The use of ketamine for anxiolysis has not been directly studied; however, ketamine has been shown to have anxiolytic effect at low doses as secondary outcomes when studied. Midazolam has been established as an effective medication to provide analgesia and anxiolysis. Investigators plan to conduct a randomized, double-blinded, controlled study in the Emergency Department. Pediatric patients presenting to the ED with the need for minor procedures who meet the inclusion and exclusion criteria will be consented, and if amenable, will be enrolled. Patients will be randomized to one of two arms of intranasal treatments: ketamine 1.0 mg/kg (K) or midazolam 0.3 mg/kg (M). Patients will be tracked for symptom improvement within the Emergency Department. The primary outcome will be change in anxiety from initial measurement to measurement 5 minutes pre-procedure using the Modified Yale Preoperative Anxiety Scale (mYPAS). Secondary outcomes will include sedation level, adverse events, need for additional medications, change in pain rating, patient and/or parent/guardian satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to one of two treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: Ketamine 100 MG/MLKetamine 100 mg/mL concentration administered in a single 1.0 mg/kg dose with a maximum of 50mg intranasal via mucosal atomization device. |
| Midazolam | Active comparator | Drug: Midazolam 5 MG/MLMidazolam 5 mg/mL concentration administered in a single administered in a single 0.3 mg/kg dose with a maximum of 5mg intranasal via mucosal atomization device. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patients age 2 to 12 years who present to the ED
- Requiring intravenous access
- Requiring laceration repairs
- Requiring incision and drainage of abscesses
- Requiring digital nerve blocks
Key exclusion criteria (17 listed)
- Vital sign abnormalities greater than 20% deviation from age-normalized ranges
- Altered mental status/delirium or intoxication
- Patient or patient's parent/guardian are unwilling to participate or provide informed consent
- Any allergy to ketamine or midazolam
- Patient is female with history of menarche
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 100 MG/MLAdminister ketamine via mucosal atomization device | Drug | Ketamine |
| Midazolam 5 MG/MLAdminister midazolam via mucosal atomization device | Drug | Midazolam |
Primary outcome
Change in mYPAS
Time frame: Change in score between initial measurement versus 5 minutes pre-procedure
Modified Yale preoperative anxiety scale
3 secondary outcomes
Change in sedation scale
Time frame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
Change in pain rating (Wong-Baker Pain Faces Rating Scale)
Time frame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
Change in anxiety score (Visual analogue scale)
Time frame: Change in score between initial measurement versus 5 minutes pre procedure, 5 minutes post procedure, and 5 minutes pre-discharge
Results and safety
The study was stopped early (reason given: Research manpower shortage). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 22688444Hosseini Jahromi SA, Hosseini Valami SM, Adeli N, Yazdi Z. Comparison of the effects of intranasal midazolam versus different doses of intranasal ketamine on reducing preoperative pediatric anxiety: a prospective randomized clinical trial. J Anesth. 2012 Dec;26(6):878-82. doi: 10.1007/s00540-012-1422-6. Epub 2012 Jun 12.
- Background: PubMed 15675259Roelofse JA, Shipton EA, de la Harpe CJ, Blignaut RJ. Intranasal sufentanil/midazolam versus ketamine/midazolam for analgesia/sedation in the pediatric population prior to undergoing multiple dental extractions under general anesthesia: a prospective, double-blind, randomized comparison. Anesth Prog. 2004;51(4):114-21.
- Background: PubMed 26417129Narendra PL, Naphade RW, Nallamilli S, Mohd S. A comparison of intranasal ketamine and intranasal midazolam for pediatric premedication. Anesth Essays Res. 2015 May-Aug;9(2):213-8. doi: 10.4103/0259-1162.154051.
- Background: PubMed 24665234Khatavkar SS, Bakhshi RG. Comparison of nasal Midazolam with Ketamine versus nasal Midazolam as a premedication in children. Saudi J Anaesth. 2014 Jan;8(1):17-21. doi: 10.4103/1658-354X.125904.
- 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.
Nadia M Pearson, MD principal investigator
Faculty Physician
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 Ketamine 100 MG/ML and Midazolam 5 MG/ML in people with Anxiety and Pediatric ALL, run by Brooke Army Medical Center 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 8 inclusion and 17 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 25 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?
The study was stopped early (reason given: Research manpower shortage). 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?
Change in mYPAS (time frame: Change in score between initial measurement versus 5 minutes pre-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03043430, which also lists 4 linked publications.
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 25 Apr 2023.