BACKGROUND: In 2001, 486 deaths and 17,300 injuries occurred in domestic fires in the UK. Domestic fires represent a significant cost to the UK economy, with the value of property loss alone estimated at pounds 375 million in 1999. In 2001 in the US, there were 383 500 home fires, resulting in 3110 deaths, 15,200 injuries and dollar 5.5 billion in direct property damage. METHODS: A cluster RCT was conducted to determine whether a smoke alarm give-away program, directed to an inner-city UK population, is effective and cost-effective in reducing the risk of fire-related deaths/injuries. Forty areas were randomized to the give-away or control group. The number of injuries/deaths and the number of fires in each ward were collected prospectively. Cost-effectiveness analysis was undertaken to relate the number of deaths/injuries to resource use (damage, fire service, healthcare and give-away costs). Analytical methods were used which reflected the characteristics of the trial data including the cluster design of the trial and a large number of zero costs and effects. RESULTS: The mean cost for a household in a give-away ward, including the cost of the program, was pounds 12.76, compared to pounds 10.74 for the control ward. The total mean number of deaths and injuries was greater in the intervention wards then the control wards, 6.45 and 5.17. When an injury/death avoided is valued at pounds 1000, a smoke alarm give-away has a probability of being cost effective of 0.15. CONCLUSIONS: A smoke alarm give-away program, as administered in the trial, is unlikely to represent a cost-effective use of resources.