NCT02706509

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-09-01
• Completion: 2018-12-01
• First posted: 2016-03-11
• Last updated: 2016-03-11