| Methods |
Design: three group parallel trial
Purpose: examine the effect of intranasal midazolam in facilitating suturing of lacerations in children |
| Participants |
Patients: preschool children with lacerations visiting an emergency department
Baseline comparability: yes |
| Interventions |
Placebo: nasal spray without midazolam
Untreated: no nasal spray
Experimental: nasal spray with midazolam
(Co‐intervention: NS) |
| Outcomes |
Anxiety (cry score)
Parent satisfaction
Heart rate
Blood pressure
Respiratory rate
Pulse oximetry
Cry score
Motion score
Struggle score |
| Notes |
Data from placebo and no‐treatment groups pooled. Contact with researchers provided unpooled data |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'Blinding was maintained for the physician by having them leave the bedside for a short interval...' |
| Blinding?
Outcome assessor |
Low risk |
'Cry... was assessed by the physician...' (See above) |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
Data from placebo and no‐treatment groups pooled. Contact with researchers provided unpooled data |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 32 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
