Efficacy of oral ketamine compared to midazolam for sedation of children undergoing laceration repair

Abstract

Objective: To assess the efficacy of oral ketamine versus oral midazolam for sedation during laceration repair at a pediatric emergency department.Methods: Children between 1 and 10 years requiring laceration repair were randomly assigned to 2 groups, treated either with oral midazolam (0.7 mg/kg) or with oral ketamine (5 mg/kg).Main outcomes measured were level of pain during local anesthesia, as assessed by the parent on a 10-cm visual analog scale (VAS) and the number of children who required intravenous sedation. Secondary outcomes included VAS by physician, pain assessment by child, maximal sedation depth assessed by the University of Michigan Sedation Scale, time until University of Michigan Sedation Scale 2 or more, general satisfaction of a parent and treating physician, length of procedure, total sedation time, and the incidence of any adverse events.Results: Sixty-eight children were recruited of which 33 were girls. Average age was 5.08 ± 2.14 years. Thirty-seven children were treated with ketamine and 31 with midazolam. Parent-assessed VAS in ketamine treated patients was 5.07 ± 0.75 compared with 3.68 ± 0.7 in midazolam treated patients [mean difference = 1.39 95% confidence interval (CI) –0.47 to 3.26]. Twelve (32%) of the children treated with ketamine required the addition of IV sedation compared to only 2 children (6%) of the children treated with midazolam [odds ratio (adjusted for age and gender) 6.1, 95% CI: 1.2 to 30.5]. The rest of the measured variables were similar between the groups, with no statistical significance.Discussion: No difference in the level of pain was found between ketamine and midazolam treated patients. Compared with oral midazolam (0.7 mg/kg), oral ketamine (5 mg/kg) was associated with higher rates of sedation failure, and thus is not recommended as a single agent for oral sedation in children requiring laceration repair.

Effect of ketamine combined with lidocaine in pediatric anesthesia

“…Existing reports have documented the appearance of less adverse reactions with ketamine used in children compared to those treated with midazolam and have ascertained lidocaine infusion to be safe with no severe side effects. 9,35 Patients receiving conjoint administration with ketamine and lidocaine exhibited significant clinical improvement in aneurysmal subarachnoid hemorrhage without any adverse reactions. 36 Pharmacological agents have been demonstrated to attenuate the hemodynamic (orthosympathetic/stress) response to tracheal intubation in pediatric patients undergoing elective surgery, thus preventing a wide array of side effects.…”

Oral Midazolam and Ketamine as Premedicants in Children- A Randomized Open Label Single Centre Study

“…Its efficacy upon oral administration was examined in various procedures, such as dental procedures, wound dressing in burns. [5] Onset of sedation was faster with midazolam in our study. The level of sedation score>3 was achieved similarly in both the groups at 45minutes.Studies have shown that achieving adequate sedation was more common in children treated with the combination of ketamine and midazolam rather than oral midazolam alone.…”

“…Rubinstein found that supplementation with intravenous drug was more in the ketamine group. [5] The two drugs have been used safely in paediatric dental procedures in the doses similar to those on our study with apparently better outcomes with midazolam. [2,10] Thus both oral midazolam and ketamine were cardiorespiratory stable.…”

“…Higher doses of midazolam and ketamine have been used in other studies. [4,5] As far as the haemodynamic parameters were concerned in the midazolam group stability was better thoughout. In the Ketamine group there was an initial rise in pulse rate and blood pressure at 15minutes followed by fall to normal basal values.…”

Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis

“…Two RCTs (Chen, 2009;Rubinstein et al, 2016) with 88 children included compared midazolam oral solution with ketamine. The RCTs indicated that the oral solution of midazolam was more successful [RR = 1.30, 95% CI (1.06, 1.59),…”