Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2016
• Main ID: NCT02760888
• Date of registration: 30/04/2016
• Prospective Registration: Yes
• Primary sponsor: Ain Shams University
• Public title: Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: OPH
• Scientific title: Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial
• Date of first enrolment: May 2016
• Target sample size: 102
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT02760888
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

Egypt

Contacts

• Name: Ahmed Elsayed Elbohoty, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- BMI raging between (18.5 - 30 ).

- Scheduled for diagnostic hysteroscopy only.

- All of them should have given informed written consent.

Exclusion Criteria:

- Any contraindication to hysteroscopy (e.g. suspected pregnancy, genital tract
infection).

- Receiving any other form of analgesia.

- Patients with known cervical stenosis, polyps and ulcers.

- Previous cervical surgery.

- Patients who are planning to have invasive intrauterine therapeutic interventions
during the hysteroscopy.

- known sensitivity to non-steroidal anti-inflammatory and opioids drugs.

- Known gastritis or peptic ulcer or cardiac disease or Respiratory dysfunction.

- Unwilling to comply with the protocol, and Participation in another clinical trial in
the last three months prior to the start of this study



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pain, Procedure

Intervention(s)

Drug: Placebo

Drug: Diclofenac

Drug: Tramadol

Primary Outcome(s)

Pain during the procedure [Time Frame: intraoperative]

pain after the procedure [Time Frame: 15 minutes after completing the procedure]

Secondary Outcome(s)

Adverse effect and difficulties [Time Frame: 24 hours]

Secondary ID(s)

EDCU HY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors