Meehan 2002.

Methods	Double‐blind, 3‐arm, parallel‐group, randomised controlled trial, with active comparator and placebo, and 1 application for 15 minutes
Participants	Setting: university paediatric emergency department, USA Sample size: Number randomised: 48 participants, 48 ears Number completed: 48 participants, 48 ears Participant baseline characteristics: Age: 1 to 18 years (mean age 3.5 years) Gender: 50% female Inclusion criteria: not stated Exclusion criteria: not stated
Interventions	Intervention group 1 (n = 15 participants; 15 ears): docusate sodium (Colace) 1 mL, wait 15 minutes, irrigation, irrigation repeated once if required Intervention group 2 (n = 17 participants; 17 ears): triethanolamine polypeptide (Cerumenex) 1 mL, wait 15 minutes, irrigation, irrigation repeated once if required Comparator group (n = 16 participants; 16 ears): saline 1 mL, wait 15 minutes, irrigation, irrigation repeated once if required Use of additional interventions: irrigation ‐ after treatment with drops was measured
Outcomes	Primary outcomes: Extent of wax clearance Secondary outcomes: Adverse effects Timing of measurements: After 15 minutes of ear drops, before irrigation After first irrigation After second irrigation if required
Funding sources	No information provided
Declarations of interest	No information provided
Notes	Participants lost to follow‐up: 8 patients withdrew
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: (from correspondence) "The assigning was done by the computer through its randomization program"
Allocation concealment (selection bias)	Low risk	Quote: (from correspondence) "The allocation was done by patient number in the pharmacy" Quote: "The test substance was concealed in a coloured syringe"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: the test substance was concealed in a coloured syringe and administered by nurses not involved in assessment
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: assessors were informed of the syringe number only and not the test substance
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: all participants were accounted for
Selective reporting (reporting bias)	Low risk	Comment: all outcomes proposed in the methods were reported in the results
Other bias	Low risk	Comment: no further sources of bias identified