Table Info

Table 1.

Main outcomes

Outcome measure	RD	BM	P-value
Therapeutic success (stops seizure < 10 min, for 1 hour, without respiratory depression)	7/12	7/12
Time from onset to administration (min)	6.0 (5–30)	6.0 (5–30)
Time from administration to seizure cessation (min)	7.0 (3–13)	7.5 (1.5–13.5)
Sedation	8/12	10/12
Respiratory depression	None	None
Ease of administration	7/12	9/12
Ultimate parental preference	1/12	9/12	P < 0.05

McNemar’s test, Wilcoxon matched-pairs signed-ranks test, and Chi-squared test were applied as appropriate. Ease of administration was recorded by parents as either “easy to give” or not. Blank cells indicate no statistically significant difference. RD: rectal diazepam; BM: buccal midazolam

Declarations

Acknowledgments

Our thanks to all the parents and carers who participated in the trial, paediatric epilepsy nurses Berni Waldron and Bernie Concanon for their support, and Jaqueline Collier for statistical guidance.

Author contributions

HWG: Formal analysis, Writing—review & editing. EW: Project administration, Writing—review & editing. WPW: Conceptualization, Data curation, Methodology, Project administration, Supervision, Writing—original draft.

Conflicts of interest

The authors declare that they have no conflicts of interest.

Ethical approval

The protocol was approved by the East Midlands-Nottingham 2 Research Ethics Committee (Q2090313), and conducted in accordance with the Good Clinical Practice guidelines of the International Conference on Harmonization (ICH) and the ethical principles of the Declaration of Helsinki.

Consent to participate

Written informed consent was obtained from all the participants’ parents/legal guardians, as all were under 16 years of age.

Consent to publication

Not applicable.

Availability of data and materials

Datasets are available on request. The raw data supporting the conclusions of this manuscript will be made available by the authors, without undue reservation, to any qualified researcher.

Funding

The study was sponsored by Nottingham University Hospitals NHS Trust [CS090301], which had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright

References

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