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A multicenter prospective interventional comparative study that investigate pain management during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of oral tramadol or 'verbal anesthesia' on the patients.
Most intrauterine contraception (IUC) insertions do not require pain management. However, small proportions of nulliparous women experience substantial pain that needs to be proactively managed No prophylactic pharmacological intervention has been adequately evaluated to support routine use for pain reduction during or after IUC insertion. Women's anxiety about the procedure may contribute to higher levels of perceived pain, which highlights the importance of counselling, and creating a trustworthy, unhurried and professional atmosphere in which the experience of the provider also has a major role; a situation frequently referred to as 'verbal anaesthesia'.
It has been proven in the past that the use of oral Tramadol can reduce the pain in the insertion.
In the study investigators will compare the analgesic affects of oral Tramadol and verbal anesthesia on pain relief during Jaydess insertion in nulliparous women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral tramadol | Active Comparator | Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted. |
|
| verbal anesthesia | Sham Comparator | 'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | patient will receive oral Tramadol 50 mg an hour before IUD insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pre-insertion therapy (oral analgesia and oral Tramadol) as pain management during insertion of Jaydess measured on a VAS (0-100 mm). | The primary outcome will be the patient evaluation of pain during the procedure. The patient will be asked to assess the pain according to VAS scale (10-100 mm) 10 minutes after the insertion of Jaydess intrauterine device. | Day of insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pain during menstruation one month after the insertion of Jaydess intrauterine device | The patient will be asked to asses the severity of pain during menstruation one month after the insertion of Jaydess intrauterine device according to VAS scale (1-100 mm) | one month after insertion |
| Evaluation of pain during menstruation six month after the insertion of Jaydess |
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Inclusion Criteria:
Exclusion Criteria:
Women suffering from:
Acute or recurrent pelvic inflammatory disease.
Acute cervicitis or acute Vaginitis.
Current cervical intraepithelial lesion.
Current any genital malignancy.
Progesterone hypersensitivity.
progesterone-sensitive tumours (e.g. breast tumours).
Abnormal vaginal bleeding.
Congenital or acquired uterine anomaly.
Distorted uterine cavity e.g. fibroid or polyp.
Impaired liver functions, or liver tumour.
Known hypersensitivity to the active substance or to any of the excipients of Jaydess.
Contraindications to Tramadol according to approved product information:
Vaginismus.
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Verbal anesthesia | Behavioral | patient will receive full explanation about the procedure for five minutes before IUD insertion |
|
| Jaydess | Device | Patient will go through an insertion of Jaydess intrauterine device. |
|
The patient will be asked to asses the severity of pain during menstruation six month after the insertion of Jaydess intrauterine device according to VAS scale (1-100 mm) |
| six month after insertion |
| Evaluation of the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device | The patient will be asked to asses the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device according to a verbal scale (non, minor, medium, sever, very sever) | one month after insertion |
| Evaluation of the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device | The patient will be asked to asses the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device according to a verbal scale (non, minor, medium, sever, very sever) | six month after insertion |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |