We read with interest the recently published research paper on
dexmedetomidine vs midazolam for sedation in mechanically ventilated
children [1]. We have the following concerns related to the study.
The recommended approach for noninferiority trials is
to perform both intention to treat and per protocol analysis and to
conclude noninferiority if both analysis produce the same result [2].
Although we could infer from the study flow chart that per protocol
analysis was done, but there could be doubt in the minds of the readers
if modified intention to treat or per protocol analysis was done. The
estimated sample size in the methods section is written as 39 per group
whereas in the discussion section the intended sample size is written as
36 in each group. Bradycardia in dexmedetomidine group is mentioned as
17.4% in the results section as well as in the fourth paragraph of
discussion section while it is mentioned as 14.4% in the first paragraph
of discussion section.
We understand your concern of not giving bolus of
dexmedetomidine in your study to avoid bradycardia and hypotension as it
has been reported in many studies. There have been few pediatric
randomized control trials in which bolus dose of dexmedetomidine was
given and there was no difference in the occurrence of bradycardia and
hypotension and they found that the rate of adequate sedation was higher
in the dexmedetomidine group with lower requirement of rescue drugs and
shorter onset of sedation time [3]. We are of the opinion that not
giving bolus dose of dexmeditomidine could have been a contributory
factor in non-establishment of non-inferiority of dexmedetomidine as
compared to midazolam in your study, and this point could have been
discussed in the discussion section.
1. Gulla KM, Sankar J, Jat KR, et al. Dexmedetomidine
vs midazolam for sedation in mechanically ventilated children: A
randomized controlled trial. Indian Pediatr. 2021;58:117-22.
2. Hahn S. Understanding noninferiority
trials. Korean J Pediatr. 2012;55:403-07.
3. Koroglu A, Demirbilek S, Teksan H, et al.
Sedative, haemodynamic and respiratory effects of dexmedetomidine in
children undergoing magnetic resonance imaging examination: preliminary
results. Br J Anaesth. 2005;94:821-24.
