Fracture Clinical Trial
— KetodexOfficial title:
Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children: an Adaptive Randomized Controlled Non-inferiority Multicenter Trial
Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of fractures in children, making them the most common fracture type. Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed reduction without the distress and pain related to IV insertion. A less painful experience has been found to correlate with child satisfaction which may reduce caregiver anxiety and improve the therapeutic relationship with the health care team. This study is a multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth of sedation as measured using the Pediatrics Sedation State Scale (PSSS).
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 17 Years |
Eligibility | INCLUSION CRITERIA General Criteria 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Deemed by treating physician to require procedural sedation Specific criteria 1. Children presenting to the paediatric EDs of participating sites age 4-17 years 2. Weighing up to and including 60 kg 3. Painful procedure including one of the following: - Forearm fracture - Metacarpal or phalangeal fracture - Dislocation of a shoulder or elbow - Type II supracondylar fracture 4. Closed reduction expected to not require more than one dose of IV sedative sedation medication (as determined by the procedure physician and not including cast or splint application). 5. Both nares are fully patent. 6. Fracture is minimally or not shortened EXCLUSION CRITERIA 1. Previous hypersensitivity reaction to ketamine or dexmedetomidine including rash, difficulty breathing, hypotension, apnea, or laryngospasm; 2. Suspected globe rupture; 3. Concomitant traumatic brain injury with intracranial hemorrhage; 4. Uncontrolled hypertension; 5. Nasal bone deformity or septal deviation; 6. Poor English or French fluency in the absence of native language interpreter; 7. American Society of Anesthesiologists (ASA) class 3 or greater; 8. Previous diagnosis of schizophrenia or active psychosis as per the treating physician 9. Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction; 10. More than one fracture or dislocation requiring reduction; 11. Hemodynamic compromise as per the treating physician; 12. Glasgow coma score < 15; 13. Previous sedation with ketamine or hematoma block within 24 hours; 14. Fracture is comminuted or associated with a dislocation; 15. Participant has undergone a hematoma block within 24 hours; 16. Obstructive sleep apnea 17. Previous enrollment in the trial; 18. Suspected pregnancy 19. Congenital heart disease or known cardiac dysrhythmia 20. Known or suspected hepatic impairment 21. Known renal insufficiency 22. Uncorrected mineralocorticoid deficiency |
Country | Name | City | State |
---|---|---|---|
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Canada | McMaster Children's Hospital | Hamilton | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | BC Children's Hospital | Vancouver | British Columbia |
Canada | Winnipeg Children's Hospital | Winnipeg | Ontario |
Lead Sponsor | Collaborator |
---|---|
Naveen Poonai |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Length of stay due to procedural sedation | Defined as the time interval from the first pair of IN sprays/IV dose to discharge, reflective of the time difference associated with different routes of administration. | Through study completion in the ED (4 hours) | |
Other | Duration of procedure | Defined as time of the first pair of IN sprays to the end of cast or splint application (closed reduction) in minutes | Through study completion in the ED (4 hours) | |
Other | Caregiver, participant, bedside nurse or respiratory therapist, and physician satisfaction | Satisfaction will be measured using a visual analog scale (VAS) when the participant is deemed ready for discharge. The following questions will be posed: How satisfied were you with your child's sedation? (Caregiver if at bedside), How happy were you with your sleep? (Participant), or How satisfied were you with the level of sedation in your patient? (Sedating physician & nurse/respiratory therapist as per who is at bedside). | Through study completion in the ED (4 hours) | |
Other | Nasal irritation | Discomfort associated with nasal sprays will be assessed by the research nurse using the Faces Pain Scale -Revised (FPS-R) when the participant is deemed ready for discharge. The FPS-R is a self-report measure scored as either 0,2,4,6,8,10, with increasing numbers indicating greater pain. | Through study completion in the ED (4 hours) | |
Other | Volume of IN intervention received / Volume of IN intervention intended | Volume of IN intervention received / Volume of IN intervention intended | Through study completion in the ED (4 hours) | |
Other | Adjunctive IV therapy and medications | The number of participants requiring an IV for therapy unrelated to sedation (eg. analgesics, antibiotics, antiemetics, fluids) will be recorded. | Through study completion in the ED (4 hours) | |
Other | Pre-sedation Pain | Will be recorded by the research nurse from the participant using the Faces Pain Scale - Revised (FPS-R) immediately prior to the first pair of intranasal sprays | Through study completion in the ED (4 hours) | |
Other | Patient Preference | The following question will be posed to the child: "If you were to be put to sleep again for an injury, what would you prefer, an intravenous needle or nasal sprays (choose one)?" | Through study completion in the ED (4 hours) | |
Other | Exploratory subgroup analyses | A planned subgroup analyses to determine whether the between group difference in adequacy of sedation is dependent on (i) pain score prior to sedation. | Through study completion in the ED (4 hours) | |
Primary | Adequate sedation | Adequate is defined as fulfillment of all three of the following criteria:
(i) A Pediatric Sedation State Scale (PSSS) score of 2 or 3 for the duration of the procedure (defined for closed reduction as the interval of time from the first application of traction or manipulation of the injured limb for the purpose of anatomical realignment to the last application of a realigning force). The PSSS is scored from 0 to 5 in discrete integer values every 15 seconds. A score of 4 or 5 indicates under-sedation and a score of 0 or 1 indicates over sedation. (ii) No additional medication is given during the procedure for the purpose of sedation. (iii) The patient did not actively resist, cry, or require physical restraint for completion of the closed reduction. |
Through study completion in the ED (4 hours) | |
Secondary | Length of stay | Defined as the time recorded in the medical record between triage and discharge. | Through study completion in the ED (4 hours) | |
Secondary | Time to wakening | This will be defined as the duration of time between the first pair of IN sprays and the first PSSS score of > 3 post-closed reduction. | Through study completion in the ED (4 hours) | |
Secondary | Adverse effects | Adverse effects as defined by Health Canada reporting standards | Through study completion in the ED and up to 72 hours post-discharge |
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