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

NCT02706509 | Unknown Phase 4 DMC

• 1 other identifier: 0063-15-MMC
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IUD Insertion Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of pain during menstruation one month after the insertion of Jaydess intrauterine device

  one month after insertion

• Evaluation of pain during menstruation six month after the insertion of Jaydess

  six month after insertion

• Evaluation of the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device

  one month after insertion

• Evaluation of the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device

  six month after insertion

Study Arms (2)

oral tramadol

ACTIVE COMPARATOR

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

Drug: Tramadol; Device: Jaydess

verbal anesthesia

SHAM COMPARATOR

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

Behavioral: Verbal anesthesia; Device: Jaydess

Interventions

Tramadol DRUG

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

Also known as: ultram

oral tramadol

Verbal anesthesia BEHAVIORAL

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

verbal anesthesia

Jaydess DEVICE

Patient will go through an insertion of Jaydess intrauterine device.

oral tramadol; verbal anesthesia

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous women aged 18-48 years, interested in a long acting, reversible contraception method. Each read and signed the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Interventions

Tramadol

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 11, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 11, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share