Sarrell 2001.

Methods	Randomisation claimed, but method not described Baseline comparability stated Double‐blind Not ITT (7 of 110 patients excluded)
Participants	Israel 103 children aged 6 to 18 years who were diagnosed with otalgia associated with AOM
Interventions	Treatment: anaesthetic ear drops (amethocaine, phenazone, glycerine) Control: naturopathic ear drops (Allium sativum, Verbascum thapsus, calendula flores, Hypericum perforatum in olive oil) Drops were instilled 3 times daily for 3 days All children were also given acetaminophen (15 mg/kg in a single dose) Duration: 3 days
Outcomes	Ear pain was assessed using 2 visual analogue scales and an overall ear pain score was determined. The first data point was assessed at the diagnosis of AOM and then pain was assessed during 3 days; before the drops were instilled, and at 15 and 30 minutes after instillation Outcome: mean pain score
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"...the children were randomly assigned to 1 of 2 treatment groups". No further information provided
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	"The study was conducted in a double‐blind, randomized manner"
Incomplete outcome data (attrition bias) All outcomes	High risk	"A total of 110 children were enrolled in the study. Seven children were excluded: 5 due to noncompliance (those who could not be reached by telephone for the interview or those who forgot to take the medication), and 2 additional children were overcome by the smell of the ear drops." Only 103 children were included in the analyses and no information about which groups the drop‐out occurred in was provided