NCT02419651

Brief Summary

The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

April 14, 2015

Last Update Submit

January 20, 2017

Conditions

Pain, Post ProceduralPain, Procedural

Keywords

out patient hysteroscopy

Outcome Measures

Primary Outcomes (1)

  • Pain during the procedure

    Women will be asked to score their pain using a visual analogue scale

    5 minutes after starting the procedure

Secondary Outcomes (1)

  • Pain after the procedure

    30 minutes after competing the procedure

Study Arms (3)

Tramadol

ACTIVE COMPARATOR

Women will receive oral Tramadol 100 mg before the procedure

Drug: Tramadol

Diclofenac

ACTIVE COMPARATOR

Women will receive oral diclofenac 100 mg before the procedure

Drug: Diclofenac

Placebo

PLACEBO COMPARATOR

Women will receive oral placebo 1 hour before the procedure.

Drug: Placebo

Interventions

TramadolDRUG

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

Tramadol
DiclofenacDRUG

Women will receive 100 mg diclofenac 1 hour before the procedure

Diclofenac
PlaceboDRUG

Women will receive a placebo 1 hour before the procedure

Placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Indication to do outpatient hysteroscopy
  • Consents to the procedure
  • Postmenstrual

You may not qualify if:

  • Known allergy to tramadol or diclofenac
  • Cardiac renal or gastric disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Ahmad G, Attarbashi S, O'Flynn H, Watson AJ. Pain relief in office gynaecology: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Mar;155(1):3-13. doi: 10.1016/j.ejogrb.2010.11.018. Epub 2011 Jan 20.

    PMID: 21255900BACKGROUND

  • van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x.

    PMID: 17516956BACKGROUND

MeSH Terms

Conditions

PainPain, Procedural

Interventions

TramadolDiclofenac

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

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
Lecturer of Gynecology and Obstetrics

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 17, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

EG(1)