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Trial record 38 of 456 for:    TRAMADOL

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

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ClinicalTrials.gov Identifier: NCT02706509
Recruitment Status : Unknown
Verified February 2016 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 11, 2016
Last Update Posted : March 11, 2016
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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.

Condition or disease Intervention/treatment Phase
IUD Insertion Complication Drug: Tramadol Behavioral: Verbal anesthesia Device: Jaydess Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparison Between the Analgesic Affects of Tramadol® and "Verbal Anesthesia" on Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
Study Start Date : March 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

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 Name: 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
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.




Primary Outcome Measures :
  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). [ Time Frame: Day of insertion ]
    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.


Secondary Outcome Measures :
  1. Evaluation of pain during menstruation one month after the insertion of Jaydess intrauterine device [ Time Frame: one month after insertion ]
    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)

  2. Evaluation of pain during menstruation six month after the insertion of Jaydess [ Time Frame: six month after insertion ]
    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)

  3. Evaluation of the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device [ Time Frame: one month after insertion ]
    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)

  4. Evaluation of the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device [ Time Frame: six month after insertion ]
    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)



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02706509     History of Changes
Other Study ID Numbers: 0063-15-MMC
First Posted: March 11, 2016    Key Record Dates
Last Update Posted: March 11, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tramadol
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents