Clinical trial NCT02706509: Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
Official title: Comparison Between the Analgesic Affects of Tramadol® and "Verbal Anesthesia" on Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IUD Insertion Complication
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of pre-insertion therapy (oral analgesia and oral Tramadol) as pain management during insertion of Jaydess measured on a VAS (0-100 mm).
timeFrame: Day of insertion
Secondary outcomes:
measure: Evaluation of pain during menstruation one month after the insertion of Jaydess intrauterine device
timeFrame: one month after insertion
measure: Evaluation of pain during menstruation six month after the insertion of Jaydess
timeFrame: six month after insertion
measure: Evaluation of the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device
timeFrame: one month after insertion
measure: Evaluation of the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device
timeFrame: six month after insertion
Other outcomes:
Locations:
Study officials:
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