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

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: IUD Insertion Complication

Treatments: Behavioral: Verbal anesthesia; Device: Jaydess; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT02706509

0063-15-MMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

oral tramadol

Active Comparator group

Description:

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

Treatment:

Drug: Tramadol

Device: Jaydess

verbal anesthesia

Sham Comparator group

Description:

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

Treatment:

Behavioral: Verbal anesthesia

Device: Jaydess