Oral Tiemonium Methylsulfate versus Placebo for Pain Relief before Outpatient Hysteroscopy: A Randomized Controlled Trial

Abstract

SUMMARY O utpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia (De Iaco et al., 2000). The use of miniature hysteroscope and the vaginoscopic approach have made outpatient hysteroscopy more feasible, more convenient and less painful for many patients. However, some patients still experience pain during the procedure, which has been reported as a common cause of failure to complete the procedure (Critchley et al., 2004; Jivraj et al., 2004). Pain associated with hysteroscopy occurs during insertion of the speculum, dilatation of the cervix for insertion of hysteroscope (non vaginoscopic approach), distention of the uterine cavity with distention medium, and direct stimulation of the uterine wall by the hysteroscope (Jivraj et al., 2004). Office hysteroscopy may be painful, even if it is performed by an experienced surgeon with a non-traumatic technique (De Iaco et al., 2000). This study aims to assess the efficacy and safety of Tiemonium methylsulfate in relief of pain associated with diagnostic hysteroscopy. 124 women, who were referred to Early Cancer Detection Unite [ECDU] to undergo diagnostic hysteroscopy at Ain Shams University Maternity Hospital for various complaints, participated in this study. The cases were randomly assigned to two groups (61patients to group I and 63 patients to group II): I- Tiemonium methylsulfate group. II- Placebo group. There was no significant difference in the pain perception between women in the Tiemonium methylsulfate group and women in the Placebo group during the procedure. Regarding the adverse reactions, none of the included women in either group had medication-related adverse reactions. There is no statistically significant difference between the two groups in Age, BMI and Preliminary diagnosis. The duration of the procedure was significantly lower in women of group I when compared to women of group II. The mean duration in the Tiemonium methylsulfate group was (4.81±1.44 SD) and in the Placebo group was (5.48±1.49SD). In summing up, we found that there was no significant difference experienced in the pain between the Tiemonium methylsulfate group and the Placebo group.