Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

Phase 3

• Conditions: Pain, Procedure
• Interventions: Drug: Placebo; Drug: Tramadol; Drug: Diclofenac

• Registration Number: NCT02760888
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.

Detailed Description

This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite \[ECDU\].

Patients fulfilling inclusion and exclusion criteria will be divided into three groups.

Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure.

Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure.

Group C (control group) Include 34 patients who will receive a placebo.

Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2016-04-30
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-03
• Last Update Submitted: 2016-05-03
• Study First Posted: 2016-05-04
• Last Update Posted: 2016-05-04
• Primary Completion: 2016-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Women will receive a placebo 1 hour before the procedure
Tramadol	Tramadol	Women will receive oral tramadol 100 mg 1 hour before the procedure
Diclofenac	Diclofenac	Women will receive 100 mg diclofenac 1 hour before the procedure

Primary Outcome Measures

Name	Time	Method
Pain during the procedure	intraoperative	Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy
pain after the procedure	15 minutes after completing the procedure	15 minutes after procedure using a 100mm line visual analog scale

Secondary Outcome Measures

Name	Time	Method
Adverse effect and difficulties	24 hours	Recorded in Case Record Form

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt