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

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

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.

Study Overview

• Status: Unknown
• Conditions: IUD Insertion Complication
• Intervention / Treatment: Drug: Tramadol; Device: Jaydess; Behavioral: Verbal anesthesia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: March 10, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: 0063-15-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No