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We thank the readers for their interest in our article [1]. The
authors have pointed out few issues; most of these were
already addressed in the article. Following are our
responses to the points highlighted [2].
(i) We have
mentioned various aspects of conduct of the trial in detail
in the study methods. The limitation of the study being an
open label study have been clearly mentioned in the
discussion. For an open label study, we took various
measures to reduce the risk of bias. However, to take care
of the bias better, a blinded study - a double dummy design
- would have to be performed. To reduce the bias, regarding
cough score, secretion score, bronchoscopist and an
independent observer assigned the scores independently
(these details were mentioned in the manuscript).
(ii) The mean and standard deviation values for oxygen
saturation are correct. A standard deviation of 1.5 or 1.4
when mean value is 99.1 does not mean that some values were
more than 100; this is a common misconception. The standard
deviation is one of the measures of dispersion. For baseline
saturation, the maximum value was 100% in both arms while
the lowest values were 94% and 95% in the propofol and
fentanyl arms, respectively; this suggests that there was a
skew to left. The median (IQR) values were 100% (98%, 100%)
and 100% (98%, 100%), respectively in the propofol and
fentanyl arms.
(iii) We have clearly highlighted the
indications for use of midazolam in the methods. After the
initial 180 seconds, there was another indication “In
addition, midazolam was administered at a dose of 0.1 mg/kg
(maximum dose of 5 mg) bolus at a time up to maximum of two
doses, for those who had inadequate sedation to continue
procedure irrespective of the arm [1]’’. The time to achieve
adequate sedation was 15.7 (4.4) seconds in propofol group
and no child received midazolam initially; however, 11
children received midazolam later during the conduct of the
procedure in the propofol group for the above-mentioned
indication.
(iv) We agree with the details of
midazolam provided by the authors. The frequency of
administration of midazolam doses in our study is supported
by the range of time of onset of action. We used the same
protocol of administration of midazolam in the two arms of
our study.
(v) In the propofol group, no child
needed midazolam to achieve appropriate sedation within
first 180 seconds; some of them had to be administered
midazolam later to maintain sedation for the overall
procedure. Therefore, the superiority of propofol over
fentanyl for the primary outcome is unlikely to be affected
by adjusting for midazolam usage.
References
1. Gunathilaka PKG, Jat KR, Sankar J, Lodha
R, Kabra SK. Propofol versus fentanyl for sedation in
pediatric bronchoscopy: A randomized controlled trial.
Indian Pediatr. 2019;56:1011-6.
2. Gautam G, Khera
AD. Sedation in pediatric broncho-scopy: Propofol versus
fentanyl. Indian Peditric. 2020;57:479-80
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