Bone FracturesPhase 3NCT02402868
Intranasal Versus Intravenous Ketamine for Procedural Sedation in Children
A Phase 3 study testing Ketamine and saline in people with Bone Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This study will examine the effectiveness of intranasal (IN) ketamine compared to standard intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the paediatric population. The aim is to assess if IN administration is equivalent to the current standard of care, IV. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Bone Fractures
- What is being tested?
- Ketamine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Feb 2018
- Phase
- Phase 3
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 5-17 years (up to 80 kg) presenting to the paediatric ED who require a PCS for an acute simple orthopedic injuries who require a procedural sedation and analgesia (PSA). A "simple" injury is defined as a fracture or dislocation that: 1) Angulated with or without displacement but is not shortened) 2) Non-comminuted
Who cannot join
- 1) Previous hypersensitivity reaction to ketamine including rash, difficulty breathing, hypotension, apnea, or laryngospasm 2) Globe rupture 3) Traumatic brain injury with intracranial hemorrhage 4) History of uncontrolled hypertension 5) Nasal bone deformity 6) Fracture reduction expected to require > 20 minutes 7) Poor English fluency 8) American Society of Anesthesiologists (ASA) class of 3 or greater 9) Previous sedation with ketamine within 24 hours of index visit 10) Known diagnosis of schizophrenia or active psychosis 11) Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A5W9
About this study
Official title: Intranasal Ketamine Versus Intravenous Ketamine for Procedural Conscious Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
This study will examine the effectiveness of intranasal (IN) ketamine compared to standard intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the paediatric population. The aim is to assess if IN administration is equivalent to the current standard of care, IV. The population to be studied is children 5-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will recieve both IV and IN interventions, only one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed using the University of Michigan Sedation Scale (UMSS).
Read the detailed description
Randomization and concealment of allocation will be pharmacy-controlled using a computer-based random number generator. The treating physician, research assistant, and participant will be blinded to the intervention. Eligible participants will be randomized in a 1:1 allocation ratio with a stratified block design of six to either (1) IN ketamine (each single dose, 8 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 1.5 mL) PLUS IV 0.9% NS 0.02 mL/kg or (2) IV ketamine (single dose, 1 mg/kg, to a maximum 100 mg) PLUS intranasal 0.9% NS 0.08 mL/kg divided to both nares. Due to the perceptible differences in interventional routes, each participant will receive both IV and IN interventions using this double-dummy approach. For IN dose volumes less than or equal to 0.5 mL, the entire dose will be delivered into 1 nostril and for doses greater than 0.5 mL, the dose will be divided equally between both nares. Adjuctive sedation will be given as needed in the form of IV ketamine, 1 mg/kg every 10 minutes for participants who do not achieve adequate sedation at 20 minutes (UMSS score of 4). A figure of the atomizer device used to deliver the IN agent has been uploaded. Eligible participants (defined in section 2.5 above) will be identified by the treating physician after viewing the radiographs and performing a clinical assessment. The physician will then inform a research assistant (RA) that the participant is eligible. The RA will then seek informed consent and explain the protocol to the family. Baseline demographic information will be obtained. Informed consent for PCS and a pre-anesthetic assessment will be performed by the treating physician in accordance with the usual standard of care. UMSS scores will be obtained by a trained RA at 5 minutes pre-intervention, intervention (0 minutes) and every 5 minutes thereafter for 60 minutes post-intervention or until the participant is ambulatory and drinking well, whichever is longer. Participants will receive standard monitoring of oxygen saturation, blood pressure, respiratory rate, apnea, heart rate, and rash by the attending nurse and physician every 5 minutes as per the usual standard of care. The usual standard of care also includes monitoring post-anesthetic for the presence of known idiosyncratic effects of ketamine that include vomiting, seizure, headache, emergence reaction, and hypersensitivity. The RA will obtain this information from the nursing record at discharge. Immediately prior to discharge, the RA will also record the duration of stay in the ED and parental satisfaction with PCS. 1. Chiaretti et al. 2011. Intranasal lidocaine and midazolam for procedural sedation in children. Arch Dis Child. 96;160-163
- Conditions
- Bone Fractures
- Being tested
- Ketamine and saline
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine and salineDrug
Also called Ketamine hydrochloride
Ketamine intravenous and intranasal
| Study group | Role | What they receive |
|---|---|---|
| Intranasal ketamine and saline | Experimental | Intranasal ketamine (each single dose, 8 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 6.4 mL) PLUS IV 0.9% NS 0.02 mL/kg Receives: Drug: Ketamine and saline |
| Intravenous ketamine and saline | Active comparator | Intravenous ketamine (single dose, 1 mg/kg, to a maximum 100 mg) PLUS intranasal 0.9% NS 0.08 mL/kg divided to both nares Receives: Drug: Ketamine and saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of Michigan Sedation Score
The primary outcome is the UMSS score at 10 minutes post administration of the IV intervention compared to UMSS score immediately prior to the first IN intervention (delta) using the University of Michigan Sedation Scale (UMSS)
Measured: From the time the IV intervention is given to 60 minutes post intervention or when drinking, whichever is longer
Secondary outcomes (15)
Onset of sedation
Time interval from first IN spray to UMSS score of greater than 3 in minutes
Measured: Within 1 hour following intervention
Duration of sedation
Time interval from UMSS score greater than 3 to a UMSS score of 0 in minutes
Measured: Within 2 hours following sedation
Adverse events
Obtained when patient fully awake and prior to discharge from the participant, physician report and corroborated with nursing sedation record
Measured: Within 2 hours following sedation
Length of stay
Time from arrival in ED bed to discharge in minutes
Measured: Within 3 hours of intervention
Length of stay due to sedation
Time from first IN spray to discharge in minutes
Measured: Within 3 hours of intervention
Duration of procedure
Time from first IN spray to end of cast application
Measured: Within 3 hours of intervention
Parental satisfaction
Obtained immediately prior to discharge using a 5-item Likert scale; Parents not wishing to remain in proximity of child for sedation may opt out
Measured: Within 2 hours of sedation
Child satisfaction
Obtained immediately prior to discharge using a 5-item Likert scale
Measured: Within 2 hours of sedation
Sedating physician satisfaction
Obtained immediately prior to discharge using a 5-item Likert scale
Measured: Duration of ED visit
Adjunctive sedative medication
Number of doses and type of adjunctive sedative medication required
Measured: Duration of ED visit
Analgesic medication
Number of doses and type of analgesic medication required
Measured: Duration of ED visit
Pain
Child's self reported pain score using the Faces Pain Scale - Revised
Measured: 15 minutes prior to and 2 hours post intervention
Emergence Agitation
Degree of emergency agitation and delirium as recorded by observer using the Paediatric Anesthesia Emergency Delirium (PAED) scale
Measured: Every 5 minutes for 60 minutes starting 20 minutes post IV intervention
Nasal Irritation
Recorded using a 5-item Likert scale anchored from 1=none to 5=very severe when child has a UMSS score of 0 and is awake and drinking
Measured: Within 1 hour of intervention
Successful sedation
Successful sedation - Based on the definition of Bhatt et al., this will be defined as no unpleasant patient recall of the procedure, no resistance or restraint required during the procedure, no permanent sedation-related complication or no sedation-related event requiring abandonment of the procedure.
Defined as: no unpleasant patient recall of the procedure, no resistance or restraint required during the procedure, no permanent sedation-related complication or no sedation-related event requiring abandonment of the procedure.
Defined as no unpleasant recall of procedure, no resistance or restraint, no permanent sedation related complication, no sedation-related event requiring abandonment of procedure
Measured: From time of first IN spray to when participant is fully awake (UMSS score of 0 for 15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen Poonai, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Naveen Poonai, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402868
- Sponsor's protocol ID
- 106549
- Status last verified
- Aug 2018
- First submitted
- 25 Mar 2015
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine Versus Intravenous Ketamine for Procedural Conscious Sedation in Children: a Multi-centre Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02402868
- Acronym / sponsor ID
- 106549
- Conditions
- Bone Fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 30 Mar 2015 (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.
This study will examine the effectiveness of intranasal (IN) ketamine compared to standard intravenous (IV) ketamine administration for simple reductions of orthopaedic injuries in the paediatric population. The aim is to assess if IN administration is equivalent to the current standard of care, IV. The population to be studied is children 5-17 years of age who require a simple orthopaedic reduction. Following a double dummy approach to overcome the difficulty in masking interventions, each participant will recieve both IV and IN interventions, only one of which will be the real drug. Procedural conscious sedation (PCS) will be assessed using the University of Michigan Sedation Scale (UMSS).
Detailed description
Randomization and concealment of allocation will be pharmacy-controlled using a computer-based random number generator. The treating physician, research assistant, and participant will be blinded to the intervention. Eligible participants will be randomized in a 1:1 allocation ratio with a stratified block design of six to either (1) IN ketamine (each single dose, 8 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 1.5 mL) PLUS IV 0.9% NS 0.02 mL/kg or (2) IV ketamine (single dose, 1 mg/kg, to a maximum 100 mg) PLUS intranasal 0.9% NS 0.08 mL/kg divided to both nares. Due to the perceptible differences in interventional routes, each participant will receive both IV and IN interventions using this double-dummy approach. For IN dose volumes less than or equal to 0.5 mL, the entire dose will be delivered into 1 nostril and for doses greater than 0.5 mL, the dose will be divided equally between both nares. Adjuctive sedation will be given as needed in the form of IV ketamine, 1 mg/kg every 10 minutes for participants who do not achieve adequate sedation at 20 minutes (UMSS score of 4). A figure of the atomizer device used to deliver the IN agent has been uploaded. Eligible participants (defined in section 2.5 above) will be identified by the treating physician after viewing the radiographs and performing a clinical assessment. The physician will then inform a research assistant (RA) that the participant is eligible. The RA will then seek informed consent and explain the protocol to the family. Baseline demographic information will be obtained. Informed consent for PCS and a pre-anesthetic assessment will be performed by the treating physician in accordance with the usual standard of care. UMSS scores will be obtained by a trained RA at 5 minutes pre-intervention, intervention (0 minutes) and every 5 minutes thereafter for 60 minutes post-intervention or until the participant is ambulatory and drinking well, whichever is longer. Participants will receive standard monitoring of oxygen saturation, blood pressure, respiratory rate, apnea, heart rate, and rash by the attending nurse and physician every 5 minutes as per the usual standard of care. The usual standard of care also includes monitoring post-anesthetic for the presence of known idiosyncratic effects of ketamine that include vomiting, seizure, headache, emergence reaction, and hypersensitivity. The RA will obtain this information from the nursing record at discharge. Immediately prior to discharge, the RA will also record the duration of stay in the ED and parental satisfaction with PCS. 1. Chiaretti et al. 2011. Intranasal lidocaine and midazolam for procedural sedation in children. Arch Dis Child. 96;160-163
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 |
|---|---|---|
| Intranasal ketamine and saline | Experimental | Drug: Ketamine and salineIntranasal ketamine (each single dose, 8 mg/kg prepared in 0.9% NS in 3 mL syringe and atomizer, to a maximum of 6.4 mL) PLUS IV 0.9% NS 0.02 mL/kg |
| Intravenous ketamine and saline | Active comparator | Drug: Ketamine and salineIntravenous ketamine (single dose, 1 mg/kg, to a maximum 100 mg) PLUS intranasal 0.9% NS 0.08 mL/kg divided to both nares |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients 5-17 years (up to 80 kg) presenting to the paediatric ED who require a PCS for an acute simple orthopedic injuries who require a procedural sedation and analgesia (PSA). A "simple" injury is defined as a fracture or dislocation that: 1) Angulated with or without displacement but is not shortened) 2) Non-comminuted
Key exclusion criteria (1 listed)
- 1) Previous hypersensitivity reaction to ketamine including rash, difficulty breathing, hypotension, apnea, or laryngospasm 2) Globe rupture 3) Traumatic brain injury with intracranial hemorrhage 4) History of uncontrolled hypertension 5) Nasal bone deformity 6) Fracture reduction expected to require > 20 minutes 7) Poor English fluency 8) American Society of Anesthesiologists (ASA) class of 3 or greater 9) Previous sedation with ketamine within 24 hours of index visit 10) Known diagnosis of schizophrenia or active psychosis 11) Pregnancy
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 and salineAlso: Ketamine hydrochlorideKetamine intravenous and intranasal | Drug | Intranasal ketamine and saline, Intravenous ketamine and saline |
Primary outcome
University of Michigan Sedation Score
Time frame: From the time the IV intervention is given to 60 minutes post intervention or when drinking, whichever is longer
The primary outcome is the UMSS score at 10 minutes post administration of the IV intervention compared to UMSS score immediately prior to the first IN intervention (delta) using the University of Michigan Sedation Scale (UMSS)
15 secondary outcomes
Onset of sedation
Time frame: Within 1 hour following intervention
Duration of sedation
Time frame: Within 2 hours following sedation
Adverse events
Time frame: Within 2 hours following sedation
Length of stay
Time frame: Within 3 hours of intervention
Length of stay due to sedation
Time frame: Within 3 hours of intervention
Duration of procedure
Time frame: Within 3 hours of intervention
Parental satisfaction
Time frame: Within 2 hours of sedation
Child satisfaction
Time frame: Within 2 hours of sedation
Sedating physician satisfaction
Time frame: Duration of ED visit
Adjunctive sedative medication
Time frame: Duration of ED visit
Analgesic medication
Time frame: Duration of ED visit
Pain
Time frame: 15 minutes prior to and 2 hours post intervention
Emergence Agitation
Time frame: Every 5 minutes for 60 minutes starting 20 minutes post IV intervention
Nasal Irritation
Time frame: Within 1 hour of intervention
Successful sedation
Time frame: From time of first IN spray to when participant is fully awake (UMSS score of 0 for 15 minutes)
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 14 Aug 2018.
- 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.
Naveen Poonai, MD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine and saline in people with Bone Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 1 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 14 Aug 2018. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
University of Michigan Sedation Score (time frame: From the time the IV intervention is given to 60 minutes post intervention or when drinking, whichever is longer). 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 14 Aug 2018.