Study design and target group
This prospective double-blind clinical trial was conducted in the ED of Isfahan Alzahra Hospital, from May 2016 to June 2017. The sedation levels and different outcomes of patients receiving low-dose intravenous ketamine bolus (intervention group) were compared to patients receiving higher dosage of intravenous ketamine (control group), for reduction of upper and lower extremity fractures. Inclusion criteria consisted of parents' desire and consent to participate in the study, body mass index (BMI) within the normal range, having age of 6 months to 17 years, requiring a reduction of upper and lower limb fractures, not receiving benzodiazepines and other sedation drugs before intervention. …show more content…
Patient assessment was performed before and two minutes after ketamine injection, and then every 5 minutes after the reduction of the fracture, by an anesthetist blind to the type of intervention.
Finally, after the intervention, the patients were put under close and direct observation in a quiet and dim room. The incidence of any side effects of ketamine injections such as gastrointestinal (nausea, vomiting, increase in salivary secretion), neurological (dizziness, headache, light-headedness, nystagmus, visual disturbance, drowsiness, numbness, or increased skeletal tone), psychological (hallucination, dysphoria or confusion, agitation, disorientation, or mood change) and cardiopulmonary (major: hypoxia and hypotension; minor: tachycardia and hypertension) were recorded by a Nurse, blinded to the intervention group; if necessary, immediate action was