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

NCT ID: NCT02706509

Last Updated: 2016-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-12-31

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.

Conditions

IUD Insertion Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

oral tramadol

Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted.

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

patient will receive oral Tramadol 50 mg an hour before IUD insertion

Jaydess

Intervention Type: DEVICE

Patient will go through an insertion of Jaydess intrauterine device.

verbal anesthesia

'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted

Group Type: SHAM_COMPARATOR

Verbal anesthesia

Intervention Type: BEHAVIORAL

patient will receive full explanation about the procedure for five minutes before IUD insertion

Jaydess

Intervention Type: DEVICE

Patient will go through an insertion of Jaydess intrauterine device.

Interventions

Tramadol

patient will receive oral Tramadol 50 mg an hour before IUD insertion

Intervention Type: DRUG

Verbal anesthesia

patient will receive full explanation about the procedure for five minutes before IUD insertion

Intervention Type: BEHAVIORAL

Jaydess

Patient will go through an insertion of Jaydess intrauterine device.

Intervention Type: DEVICE

Other Intervention Names

ultram

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0063-15-MMC

Identifier Type: -

Identifier Source: org_study_id