A Phase 3 interventional study of Ketamine and saline in Bone Fractures, sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's · Phase 3, Interventional, and Treatment
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).
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
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 17 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's is the lead sponsor of 352 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Ketamine and saline
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
Drug: Ketamine and saline
Ketamine intravenous and intranasal
Also known as: Ketamine hydrochloride
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)
Time frame: From the time the IV intervention is given to 60 minutes post intervention or when drinking, whichever is longer
Onset of sedation
Time interval from first IN spray to UMSS score of greater than 3 in minutes
Time frame: Within 1 hour following intervention
Duration of sedation
Time interval from UMSS score greater than 3 to a UMSS score of 0 in minutes
Time frame: 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
Time frame: Within 2 hours following sedation
Length of stay
Time from arrival in ED bed to discharge in minutes
Time frame: Within 3 hours of intervention
Length of stay due to sedation
Time from first IN spray to discharge in minutes
Time frame: Within 3 hours of intervention
Duration of procedure
Time from first IN spray to end of cast application
Time frame: 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
Time frame: Within 2 hours of sedation
Child satisfaction
Obtained immediately prior to discharge using a 5-item Likert scale
Time frame: Within 2 hours of sedation
Sedating physician satisfaction
Obtained immediately prior to discharge using a 5-item Likert scale
Time frame: Duration of ED visit
Adjunctive sedative medication
Number of doses and type of adjunctive sedative medication required
Time frame: Duration of ED visit
Analgesic medication
Number of doses and type of analgesic medication required
Time frame: Duration of ED visit
Pain
Child's self reported pain score using the Faces Pain Scale - Revised
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From time of first IN spray to when participant is fully awake (UMSS score of 0 for 15 minutes)
Plan to share: No
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London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's