Results
A total of 80 children were screened for the study. Two children did not meet inclusion criteria (one had an abnormal neurologic examination and one was obese). In 18 cases, the parents refused to participate in the study (Figure 1). Sixty children were included in the study and were randomly assigned into one of two groups: 29 children in the 'placebo group' received midazolam and placebo, and 31 children in the 'research group' received midazolam and ketamine. There were no significant differences in the demographic data (age, sex and weight) between the two groups. ( Table 1 ) Most children suffered from facial lacerations (86% in the placebo group vs 74% in the research group, p=0.33), mostly of the forehead and chin. Other sites of lacerations included: fingers and toes, flank and forearms.
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Figure 1.
Patients' recruitment and allocation.
The study outcome measures are described in Table 2 . Time course to achieving a sedation scale ≤4 was similar in the two groups. The time from administration of sedation to the beginning of the procedure was also comparable between both groups. Sedation score was lower in the research group than in the placebo group, with a mean of 2.36±0.89 and 3.5±0.67, respectively (mean difference 1.14, 95% CI 0.67 to 1.6). Two (6%) children in the research group and eight (27%) in the placebo group required intravenous sedation (p=0.039). Procedure time was significantly longer in the research group (15.75±6.53 min) than in the placebo group (10.9±5.32 min), (mean difference 4.85 min 95% CI 1.28 to 8.42).
VAS score at the time of local anaesthetic injection, was comparable between the two groups, both by a parent (4.40±2.78 cm and 4.50±3.33 cm, respectively, and by an investigator (4.49±3.16 cm and 4.05±2.87 cm, respectively). Time to discharge from the ED was longer in the research group than in the placebo group (mean difference 65 min 95% CI 22 to 107).
No severe adverse effects were noted during the procedure and recovery in the ED. In the research group, three children (9%) suffered from vomiting; one child had a desaturation episode (SO2 <90%) that lasted for a few seconds and spontaneously resolved, and two children were agitated after recovery. In the placebo group, one child had mildly low blood pressure, and one child was agitated. All adverse effects were mild, resolved spontaneously and did not require any medical intervention.