To investigate the effects of music and/or tramadol on pain and anxiety in burn outpatients undergoing dressing changes. Randomized controlled trial. Burns and Plastic Reconstruction Unit. Patients (N=180) with burns on up to 10%-30% of the total body surface area (TBSA). The patients were randomly allocated to 4 equal-sized groups as follows: (1) tramadol group (TG), patients received 100mg of tramadol orally 20min before the dressing change; (2) music group (MG), patients listened to self-selected music during the dressing change; (3) music-plus-tramadol group (MTG), patients received tramadol and listened to self-selected music; and (4) control group (CG), patients received a routine dressing change only. All patients underwent the interventions once per day for 2days. McGill Pain Questionnaire Short Form (MPQ-SF) (primary outcome), McGill Pain Persian version of Burn Specific Pain Anxiety Scale (BSPAS) (primary outcome), and heart rate (HR) and overall patient satisfaction (secondary outcomes). The results showed that music-plus-tramadol group (MTG) had better outcomes with respect to pain and anxiety management during dressing changes. In comparison with music or tramadol alone, the integration of music and tramadol offers a secure and favorable treatment choice to relieve pain and anxiety, ultimately improving the satisfaction levels of burn outpatients during dressing changes. Copyright © 2019 Elsevier Ltd and ISBI. All rights reserved.