Table 2

Schedule of activities

ProceduresPresenting ED visit
Presenting ED visit
First pair of intranasal sprays30–40 min after intranasal dexmedetomidine/
saline sprays
Immediately prior to closed reductionClosed reductionImmediately prior to cast/splint applicationImmediately after cast/splint applicationImmediately prior to discharge24–48 hours postdischarge
Vital signs at triage*×
Assessment of eligibility×
Informed consent××
Medical history×
Randomisation (intravenous ketamine vs intranasal Ketodex)×
Preintervention pain score×
Randomisation (intranasal Ketodex combinations)×
Administration of intranasal intervention†×
Administration of intravenous intervention×
Video recording begins‡×
Video recording ongoing×
Video recording ends×
Satisfaction recorded from bedside nurse, sedating physician and procedure physician ×
Nasal irritation recorded from participant×
Satisfaction recorded from participant and caregiver ×
Adverse events recorded×——————————————————————————————————×
Video scoring¶×
  • *Vital signs are normally collected during triage and therefore will always be recorded prior to prescreening for all potential study participant.

  • †The maximum dose volume administered using the mucosal atomiser device is 0.5 mL per nostril. The administration of each pair of 0.5 mL sprays will be separated by at least 60 s.

  • ‡Video recording will start immediately prior to the closed reduction and will continue until the closed reduction is complete, prior to cast/splint application.

  • §The PHBQ will be administered either by automatic email from REDCap or by telephone, depending on the participant’s preference.

  • ¶Video scoring using the Paediatric Sedation State Scale will be done by two blinded outcome assessors remote from clinical encounter.

  • ED, emergency department; PHBQ, posthospital behaviour questionnaire.