Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

Ain Shams University102 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

102

Conditions

Pain, Procedure

Interventions

TramadolDRUG

Women will receive a oral Tramadol 100mg 1 hour before the procedure

DiclofenacDRUG

Women will receive oral Diclofenac 100mg 1 hour before the procedure

PlaceboDRUG

Women will receive a Placebo 1 hour before the procedure

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

Pain during the procedure

Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy

Time frame: intraoperative

pain after the procedure

15 minutes after procedure using a 100mm line visual analog scale

Time frame: 15 minutes after completing the procedure

Secondary Outcomes

Adverse effect and difficulties

Recorded in Case Record Form

Time frame: 24 hours

Central Contacts

Ahmed Elsayed Elbohoty, MD

CONTACT

elbohoty79@yahoo.com

Data from ClinicalTrials.gov

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