Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02760888

Acronym

OPH

Enrollment

102

Registered

2016-05-04

Start date

2016-05-31

Completion date

2016-07-31

Last updated

2016-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Procedure

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.

Interventions

DRUGTramadol

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

DRUGDiclofenac

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

DRUGPlacebo

Women will receive a Placebo 1 hour before the procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adverse effect and difficulties	24 hours	Recorded in Case Record Form

Countries

Egypt

Contacts

Primary ContactAhmed Elsayed Elbohoty, MD

elbohoty79@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026