Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Between the Analgesic Affects of Tramadol® and Verbal Anesthesia on Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women

Conditions
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IUD Insertion Complication

Intervention / Treatment
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* Drug: Tramadol
* Behavioral: Verbal anesthesia
* Device: Jaydess


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous women aged 18-48 years, interested in a long acting, reversible contraception method. Each read and signed the informed consent. 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: In hypersensitivity to tramadol or any of the excipients. In patients who are receiving monoamine oxidase inhibitors or within 2 weeks (14 days) of their withdrawal. In patients with epilepsy not adequately controlled by treatment. Vaginismus.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral tramadol<br>Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted. | Drug: Tramadol<br>* patient will receive oral Tramadol 50 mg an hour before IUD insertion<br>* Other names: ultram;Device: Jaydess<br>* Patient will go through an insertion of Jaydess intrauterine device.<br>|
| Sham Comparator: verbal anesthesia<br>'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted | Behavioral: Verbal anesthesia<br>* patient will receive full explanation about the procedure for five minutes before IUD insertion<br>Device: Jaydess<br>* Patient will go through an insertion of Jaydess intrauterine device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |