Pain relief during and following outpatient curettage and hysterosalpingography: a double blind study to compare the efficacy and safety of tramadol versus naproxen. Cobra Research Group.
OBJECTIVE
To compare the analgetic efficacy and side-effects of Naproxen and Tramadol following the outpatient VABRA aspiration or hysterosalpingography.


METHODS
Ninety-one patients from the gynaecology clinics of two university hospitals and one municipal-teaching hospital.


METHODS
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.


CONCLUSIONS
Tramadol is a good alternative for Naproxen at outpatient VABRA or HSG procedures when Naproxen is contra-indicated.
Peters
A A
AA
Department of Obstetrics and Gynaecology, Leiden University Medical Center, Acedemic Hospital Leiden, The Netherlands.
Witte
E H
EH
Damen
A C
AC
Holm
J P
JP
Drogendijk
A C
AC
vd Velde
E A
EA
Trimbos
J B
JB
D000328:Adult; D000553:Ambulatory Care / Q000379:methods*; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D002395:Catecholamines / Q000494:pharmacology; D003475:Curettage / Q000009:adverse effects; D004311:Double-Blind Method; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007047:Hysterosalpingography / Q000009:adverse effects; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy*; D014147:Tramadol / Q000009:adverse effects / Q000627:therapeutic use*
D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D002395:Catecholamines; D014147:Tramadol; D009288:Naproxen