| Methods |
Block randomisation
Baseline comparability documented. Patients, treating clinicians and outcome assessors were all unaware of treatment assignment
ITT analysis |
| Participants |
Australia
Children aged between 3 and 17 years who presented to an emergency department with ear pain of less than 3 days duration and evidence of AOM |
| Interventions |
Treatment: anaesthetic ear drops (2% aqueous lignocaine drops)
Control: normal saline drops (aqueous solution)
Duration: 30 minutes
If the patient had not received analgesia in the preceding 4 hours, they were offered 15 mg/kg paracetamol. Further oral analgesia was offered between 10 (T10) and 30 minutes (T30) of the study period at the discretion of the treating doctor |
| Outcomes |
Ear pain was assessed by means of 2 visual analogue scales at baseline, 10, 20, 30 minutes after instillation, and an average ear pain score was determined
Four measures were used:
1) proportion of subjects who showed 50% reduction;
2) proportion of subjects who showed 25% reduction; and
3) proportion of participants showing a 2‐point reduction in pain score |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"The drops were randomised in blocks of 10" |
| Allocation concealment (selection bias) |
Unclear risk |
No mention of sequentially numbered, opaque, sealed envelopes or of central randomisation by a third party |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
"Patients and parents, those administering ear drops and those assessing ear pain were blinded to group assignment." |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
"On the basis of an intention to treat analysis, two patients were retained in the study and analysed despite pain resolution subsequent to enrolment with a pain score of zero at T0". Numbers in Table 2 indicate all participants were included in the analyses |
