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The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled
Anna Heath1,2,3, Juan David Rios4, Eleanor Pullenayegum4,5
1Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada. anna.heath@sickkids.ca.
Insights
Intranasal ketamine and dexmedetomidine (ketodex) offers a needle-free alternative for pediatric procedural sedation and analgesia (PSA). This study determined optimal dosing and effectiveness compared to IV ketamine for fracture reductions.
Area of Science:
- Pediatric Emergency Medicine
- Pharmacology
- Clinical Trials
Background:
- Procedural sedation and analgesia (PSA) is crucial for pediatric fracture and dislocation reductions.
- Intravenous (IV) ketamine is standard, but IV insertion is distressing for children.
- Intranasal (IN) ketamine and dexmedetomidine (ketodex) is a potential needle-free alternative.
Purpose of the Study:
- To evaluate if IN ketodex is non-inferior to IV ketamine for adequate sedation in pediatric closed reductions.
- To determine the optimal combination dose of IN ketodex for procedural sedation.
- To compare secondary outcomes including emergency department length of stay, time to wakening, and adverse events.
Main Methods:
- A multicenter, randomized, double-dummy controlled, Bayesian adaptive phase II/III trial.
- Four-arm study comparing IN ketodex to IV ketamine.
- Primary outcome: Adequate sedation measured by the Pediatric Sedation State Scale.
Main Results:
- This statistical analysis plan details the methodology for the Ketodex trial.
- The trial aims to provide evidence on the optimal dose and effectiveness of IN ketodex.
- Bayesian analysis will be employed to reduce bias and data-driven results.
Conclusions:
- The Ketodex trial will offer crucial data on IN ketodex for pediatric procedural sedation.
- Findings will guide the optimal use of this needle-free sedation alternative.
- Results will inform clinical practice for children undergoing fracture and dislocation reductions.
Background:
Procedural sedation and analgesia (PSA) is frequently required to perform closed reductions for fractures and dislocations in children. Intravenous (IV) ketamine is the most commonly used sedative agent for closed reductions. However, as children find IV insertion a distressing and painful procedure, there is need to identify a feasible alternative route of administration. There is evidence that a combination of dexmedetomidine and ketamine (ketodex), administered intranasally (IN), could provide adequate sedation for closed reductions while avoiding the need for IV insertion. However, there is uncertainty about the optimal combination dose for the two agents and whether it can provide adequate sedation for closed reductions. The Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation (Ketodex) study is a Bayesian phase II/III, non-inferiority trial in children undergoing PSA for closed reductions that aims to address both these research questions. This article presents in detail the statistical analysis plan for the Ketodex trial and was submitted before the outcomes of the trial were available for analysis.
Methods/Design:
The Ketodex trial is a multicenter, four-armed, randomized, double-dummy controlled, Bayesian response adaptive dose finding, non-inferiority, phase II/III trial designed to determine (i) whether IN ketodex is non-inferior to IV ketamine for adequate sedation in children undergoing a closed reduction of a fracture or dislocation in a pediatric emergency department and (ii) the combination dose for IN ketodex that provides optimal sedation. Adequate sedation will be primarily measured using the Pediatric Sedation State Scale. As secondary outcomes, the Ketodex trial will compare the length of stay in the emergency department, time to wakening, and adverse events between study arms.
Discussion:
The Ketodex trial will provide evidence on the optimal dose for, and effectiveness of, IN ketodex as an alternative to IV ketamine providing sedation for patients undergoing a closed reduction. The data from the Ketodex trial will be analyzed from a Bayesian perspective according to this statistical analysis plan. This will reduce the risk of producing data-driven results introducing bias in our reported outcomes.
Trial Registration:
ClinicalTrials.gov NCT04195256 . Registered on December 11, 2019.
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