Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:

NCT02760888 | Unknown Phase 3

• 1 other identifier: EDCU HY
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Procedure

Outcome Measures

Primary Outcomes (2)

• Pain during the procedure

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

  intraoperative

• pain after the procedure

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

  15 minutes after completing the procedure

Secondary Outcomes (1)

• Adverse effect and difficulties

  24 hours

Study Arms (3)

Tramadol

ACTIVE COMPARATOR

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

Drug: Tramadol

Diclofenac

ACTIVE COMPARATOR

Women will receive 100 mg diclofenac 1 hour before the procedure

Drug: Diclofenac

Placebo

PLACEBO COMPARATOR

Women will receive a placebo 1 hour before the procedure

Drug: Placebo

Interventions

Tramadol DRUG

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

Tramadol

Diclofenac DRUG

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

Diclofenac

Placebo DRUG

Women will receive a Placebo 1 hour before the procedure

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI raging between (18.5 - 30 ).
• Scheduled for diagnostic hysteroscopy only.
• All of them should have given informed written consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Tramadol; Diclofenac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Central Study Contacts

Ahmed Elsayed Elbohoty, MD

CONTACT

elbohoty79@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Obstetrics and Gynecology Faculty of Medicine Ain Shams University

Study Record Dates

• First Submitted: April 30, 2016
• First Posted: May 4, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 4, 2016

Record last verified: 2015-12

Locations

EG (1)