TerminatedNCT03781817Updated Apr 20, 2023Results posted

Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children With Non-operative Fractures

A Phase 4 interventional study of Intravenous Ketamine and Intranasal Ketamine in Trauma, Fractures, Closed and Children, Only, sponsored by University of Alabama at Birmingham. Terminated at 1 site in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2023-04-20.

Primary conditionFractures, ClosedRegistry: Wounds and InjuriesReclassifiedWhy we changed it

Registry

Wounds and Injuries — the first condition term the registry derived for this study.

ClinicalTrials.gg

Fractures, Closed

Why

The study's listed conditions name Fractures, Closed, a narrower term within Wounds and Injuries.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment

Why this study was terminated

Transition/change of primary investigators

Phase: Phase 4
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 1 Year to 18 Years
Sex: All

Study summary

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 studied

Trauma
Fractures, Closed
Children, Only
Deep Sedation
Ketamine

Browse trials for

Wounds and Injuries 2,217Registry's first term
Fractures, Closed 44Primary · reclassified
Fractures, Bone 723
Emergencies 1,328

Keywords

procedural sedation
ketamine
pediatric
fracture
intranasal
intravenous
emergency department

In context

Fractures, Closed Reclassified

44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 34 interventional studies indexed under Fractures, Closed.

Browse Fractures, Closed studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.

Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.

Browse University of Alabama at Birmingham studies →

Compared within Fractures, Closed, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →

Who can participate

Ages eligible: 1 Year to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Children 1-18 years of age.
(ASA) I or II
Non-operative fracture requiring reduction
Body weight less than or equal to 25 kg as measured by standard weighing scale

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status: The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 40 participants (actual)

Study arms

Active comparator
Intravenous ketamine
Participants randomized to IV ketamine will be receive IV ketamine and Intranasal normal saline.
Drug: Intravenous Ketamine
Experimental
Intranasal ketamine
Participants randomized to Intranasal Ketamine group will receive Intranasal ketamine and IV normal saline.
Drug: Intranasal Ketamine

Interventions

DrugIntravenous Ketamine
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.
DrugIntranasal Ketamine
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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: From induction to discharge from sedation by emergency physician, up to 3 hours.

Secondary outcomes

Percentage of Participants With Non-serious Adverse Events.
Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.
Time frame: 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.
Time frame: 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.
Time frame: From arrival to emergency department to discharge order entered by emergency physician.

Results

Posted Apr 20, 2023

Participant flow

Patient screening, enrollment and informed consent will be obtained in the emergency department (ED) of Children's of Alabama (COA). Data collection will take place in the ED as well as in Children's Park Place, Suite 110. The remainder of the research, including data analysis, and collaboration amongst the principal investigator and the sub-investigators, will be conducted in Children's Park Place, Suite 110.

Participant flow — Overall Study
Milestone	Intravenous Ketamine	Intranasal Ketamine
Started	17	23
Completed	17	23
Not completed	0	0

Outcome measures

PrimaryNumber 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.

Time frame:: Induction up to 10 minutes
Reported as:: Count of participants · Participants

Number of Participants Who Achieved Adequate Sedation.
Participants	Intravenous Ketamine	Intranasal Ketamine
Number of Participants Who Achieved Adequate Sedation.	17	4

PrimaryPercentage 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.

Time frame:: From induction to discharge from sedation by emergency physician, up to 3 hours.
Reported as:: Count of participants · Participants

Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.
Participants	Intravenous Ketamine	Intranasal Ketamine
Percentage of Adequately Sedated Participants Successfully Completing the Procedure Without Requiring Rescue Medications.	7	22

SecondaryPercentage of Participants With Non-serious Adverse Events.

Non-serious adverse events include allergic reaction, vomiting, emergence agitation, and oxygen desaturations.

Time frame:: From induction to discharge from the emergency department.
Reported as:: Count of participants · Participants

Percentage of Participants With Non-serious Adverse Events.
Participants	Intravenous Ketamine	Intranasal Ketamine
Yes	1	3
No	16	20

SecondaryDuration 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.

Time frame:: From induction to discharge from sedation by the emergency physician.
Reported as:: Mean · Minutes

Duration of Sedation Using Modified Ramsay Sedation Scale.
Minutes	Intravenous Ketamine	Intranasal Ketamine
Duration of Sedation Using Modified Ramsay Sedation Scale.	65.71 ± 32.54	101.21 ± 52.4

SecondaryDuration of Emergency Department Stay.

Measured from time of arrival to emergency department to discharge order.

Time frame:: From arrival to emergency department to discharge order entered by emergency physician.
Reported as:: Mean · Time (in minutes)

Duration of Emergency Department Stay.
Time (in minutes)	Intravenous Ketamine	Intranasal Ketamine
Duration of Emergency Department Stay.	325.65 ± 104.7	312.4 ± 67.7

Adverse events

Collected over From the time the induction medication (either intranasal ketamine or intranasal hypertonic saline) to discharge order by the emergency physician, up to 6 hours.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Intravenous Ketamine	0/17 (0%)	0/17 (0%)	1/17 (5.9%)
Intranasal Ketamine	0/23 (0%)	0/23 (0%)	3/23 (13%)

Most frequent other events

Most frequent other events
Event	Intravenous Ketamine	Intranasal Ketamine
VomitingGastrointestinal disorders	1/17	3/23

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Intravenous Ketamine	Intranasal Ketamine	Total
Median	5 ± 1.65	5 ± 1.99	5 ± 1.83

Sex: Female, Male
Sex: Female, Male(Participants)	Intravenous Ketamine	Intranasal Ketamine	Total
Female	7	9	16
Male	10	14	24

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Intravenous Ketamine	Intranasal Ketamine	Total
Hispanic or Latino	3	4	7
Not Hispanic or Latino	14	19	33
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Intravenous Ketamine	Intranasal Ketamine	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	7	10
White	14	16	30
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Allergies
Allergies(Participants)	Intravenous Ketamine	Intranasal Ketamine	Total
Yes	0	1	1
No	17	22	39

Weight (kg)
Weight (kg)(weight in kilograms)	Intravenous Ketamine	Intranasal Ketamine	Total
Mean	18.1 ± 3.2	18.4 ± 4.13	18.15 ± 3.72

Past Medical History
Past Medical History(Participants)	Intravenous Ketamine	Intranasal Ketamine	Total
Yes	1	4	5
No	16	19	35

Past Surgical History
Past Surgical History(Participants)	Intravenous Ketamine	Intranasal Ketamine	Total
Yes	1	3	4
No	16	20	36

Study locations

1 site

University of Alabama at Birmingham
Birmingham, Alabama 35233, United States

References and documents

Study documents

Protocol, analysis plan and consent form ↗ · Apr 2, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03781817
Lead sponsor: University of Alabama at Birmingham
Responsible party: James Statler (Pediatric Emergency Medicine Fellow, University of Alabama at Birmingham) — Principal investigator
First posted: Dec 20, 2018
Start date: Sep 9, 2019
Primary completion: Jan 21, 2022
Completion: Apr 30, 2022
Results posted: Apr 20, 2023
Last update: Apr 20, 2023

Study contacts

James Statler, MD

study chair · Emory University

Judson Barber, MD

principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Intranasal Ketamine

Other studies in this condition

Fractures, Closed →

Other studies from this sponsor

University of Alabama at Birmingham →

Start the discussion