Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 471 for:    TRAMADOL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 17, 2016
First Posted Date  ICMJE March 11, 2016
Last Update Posted Date March 11, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2016)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
Official Title  ICMJE Comparison Between the Analgesic Affects of Tramadol® and "Verbal Anesthesia" on Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE IUD Insertion Complication
Intervention  ICMJE
  • Drug: Tramadol
    patient will receive oral Tramadol 50 mg an hour before IUD insertion
    Other Name: ultram
  • 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.
Study Arms  ICMJE
  • Active Comparator: oral tramadol
    Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted.
    Interventions:
    • Drug: Tramadol
    • Device: Jaydess
  • Sham Comparator: verbal anesthesia
    'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted
    Interventions:
    • Behavioral: Verbal anesthesia
    • Device: Jaydess
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 10, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02706509
Other Study ID Numbers  ICMJE 0063-15-MMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Meir Medical Center
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP