OBJECTIVE: To compare the analgetic efficacy and side-effects of Naproxen and Tramadol following the outpatient VABRA aspiration or hysterosalpingography. SETTING:Ninety-one patients from the gynaecology clinics of two university hospitals and one municipal-teaching hospital. DESIGN: Multicentre double blind randomized clinical trial. Computerised randomisation, stratification per-centre. METHODS: Semiquantitative assessment of the two drugs was performed by the patient and the gynaecologist using a 1- to 6-point scale. Pain, stress and well-being was scored by the patient using the visual analog scale (VAS) and the verbal description scale (VDS), ranging from 0 (good) to 100 (bad). Side-effects during the first 24 h postoperatively were recorded by the patient in a diary. RESULTS: The analgetic efficacy (pain, stress and well-being) of Naproxen and Tramadol was identical. Subjective assessment by the patient and the doctor also revealed no differences between Naproxen and Tramadol. Side-effects of Tramadol, however, were significantly more severe than those of Naproxen and this phenomenon was responsible for a lower ability to proceed with normal activities in the Tramadol group. CONCLUSION:Tramadol is a good alternative for Naproxen at outpatient VABRA or HSG procedures when Naproxen is contra-indicated.
RCT Entities:
OBJECTIVE: To compare the analgetic efficacy and side-effects of Naproxen and Tramadol following the outpatientVABRA aspiration or hysterosalpingography. SETTING: Ninety-one patients from the gynaecology clinics of two university hospitals and one municipal-teaching hospital. DESIGN: Multicentre double blind randomized clinical trial. Computerised randomisation, stratification per-centre. METHODS: Semiquantitative assessment of the two drugs was performed by the patient and the gynaecologist using a 1- to 6-point scale. Pain, stress and well-being was scored by the patient using the visual analog scale (VAS) and the verbal description scale (VDS), ranging from 0 (good) to 100 (bad). Side-effects during the first 24 h postoperatively were recorded by the patient in a diary. RESULTS: The analgetic efficacy (pain, stress and well-being) of Naproxen and Tramadol was identical. Subjective assessment by the patient and the doctor also revealed no differences between Naproxen and Tramadol. Side-effects of Tramadol, however, were significantly more severe than those of Naproxen and this phenomenon was responsible for a lower ability to proceed with normal activities in the Tramadol group. CONCLUSION:Tramadol is a good alternative for Naproxen at outpatientVABRA or HSG procedures when Naproxen is contra-indicated.