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Table 2 Outcome variables

From: Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol

Primary outcome

 Success rate of sedation (PSSS = 1, 2, or 3) within 15 min from sedative administration

Secondary outcome

 Onset time of sedation (PSSS = 1, 2, or 3)

 Duration of sedation, from onset time to recovery time (PSSS = 4 or 5)

 Sedation failure (PSSS = 4 or 5) after 30 min from administration

  Rescue sedation agent (or method)

 Type of procedure

  Completion of procedure

  Causes of procedure failure

 Total cost of sedation

 PSSS, heart rate, respiration rate, SpO2 at baseline and every 10 min (blood pressure is measured when heart rate is < 70% of baseline)

 The incidence of PSSS = 0 (abnormal physiologic parameter that require acute intervention)

  The incidence of significant apnea (> 20 s)

  The incidence of significant desaturation (SpO2 < 95% or < − 10% from baseline, > 10 s)

  The incidence of respiratory intervention: manual ventilation or artificial airway

  The lowest SpO2 value (%)

  The incidence of significant bradycardia (− 30% from baseline)

  The incidence of significant hypotension (− 30% from baseline)

  The incidence of hemodynamic intervention (fluid management, intravenous medication)

Patients’ acceptance (1 = excellent, 2 = good, 3 = fair, 4 = poor)

Separation anxiety (1 = easy, 2 = whimper, 3 = cry, 4 = cry and cling to parents)

Physicians’ satisfaction (1 = excellent, 2 = good, 3 = fair, 4 = poor)

Other side effects (e.g., nausea/vomit, allergic reaction)

  1. PSSS Pediatric Sedation State Scale [40], SpO2 oxygen saturation