Tramadol Versus Celecoxib in Reducing Pain Associated With IUD Insertion: A Double Blind Placebo Controlled Trial

The intrauterine device (IUD) is a commonly used long-acting, effective and reversible method of contraception. IUD insertion is usually associated with a variable degree of pain. The majority of women experience mild pain or discomfort during IUD insertion, and some women may experience severe pain. Nulliparous women, women who delivered only by cesarean section and women remote from vaginal delivery are subgroups of women who experience more pain during IUD insertion. Prophylactic pharmacological interventions for management of pain associated with IUD insertion include nonsteroidal anti-inflammatory drugs (NSAIDs), opioid analgesics including Tramadol. Tramadol hydrochloride is an orally active centrally acting synthetic opioid. It is an atypical analgesic with a dual mechanism of action: serotonin and norepinephrine reuptake inhibition and modest l-opioid agonist. It has a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents. Cervical ripening with prostaglandins was suggested facilitate the introduction of the IUD through the cervix, although at the cost of increased pain due to uterine cramping.

The study objective is to compare the effectiveness and side effects of oral Tramadol 100mg versus oral Celecoxib 200mg in reducing pain associated with operative outpatient hysteroscopy in an attempt to find the most effective drug with the least possible side effects to be used before IUD insertion.

Two hundred and ten women requesting IUD insertion will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

The researchers will performed bimanual examination, introduce a speculum into the vagina and sterilized the cervix with povidone iodine before inserting the IUD according to the manufacturer recommendations.

After insertion of the IUD the women's pain perception will be assessed using a visual analogue scale (VAS) graduated from zero to 10 with zero corresponding to no pain and 10 corresponding to the worst possible pain.