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

IUD Insertion Complication Clinical Trial

— Jaydess  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02706509
• Other study ID #: 0063-15-MMC
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 17, 2016
• Last updated: March 10, 2016
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2016
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• IUD Insertion Complication

Intervention

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

Behavioral:
• Verbal anesthesia
patient will receive full explanation about the procedure for five minutes before IUD insertion

Device:
• Jaydess
Patient will go through an insertion of Jaydess intrauterine device.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes