NCT02068209

Brief Summary

The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during outpatient hysteroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

February 16, 2014

Last Update Submit

April 3, 2015

Conditions

Pain

Keywords

Outpatient hysteroscopyTramadol

Outcome Measures

Primary Outcomes (1)

  • Pain perceived by the patient during the procedure

    Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.

    10 minutes after starting the procedure.

Secondary Outcomes (1)

  • Pain perceived by the patient 30 minutes after the procedure.

    30 minutes after the procedure.

Study Arms (2)

Tramadol

ACTIVE COMPARATOR

Patients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy

Drug: Tramadol

Placebo

PLACEBO COMPARATOR

Patients will receive a placebo 1 hour before the procedure.

Drug: Placebo

Interventions

TramadolDRUG

patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.

Also known as: Tramadol 50mg
Tramadol
PlaceboDRUG

patients will receive a placebo 1 hour before outpatient hysteroscopy

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for outpatient hysteroscopy
  • Consent to the procedure

You may not qualify if:

  • Premenstrual patients
  • Known cardiac disease
  • Known allergy to Tramadol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (5)

  • Floris S, Piras B, Orru M, Silvetti E, Tusconi A, Melis F, Tuveri M, Piga M, Paoletti AM, Melis GB. Efficacy of intravenous tramadol treatment for reducing pain during office diagnostic hysteroscopy. Fertil Steril. 2007 Jan;87(1):147-51. doi: 10.1016/j.fertnstert.2006.05.072. Epub 2006 Nov 1.

    PMID: 17081540BACKGROUND

  • Sharma JB, Aruna J, Kumar P, Roy KK, Malhotra N, Kumar S. Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009 Jun;63(6):244-52.

    PMID: 19602758BACKGROUND

  • 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

  • O'Flynn H, Murphy LL, Ahmad G, Watson AJ. Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice. Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):9-15. doi: 10.1016/j.ejogrb.2010.08.015.

    PMID: 20926175BACKGROUND

  • Modi H, Mazumdar B, Bhatt J. Study of interaction of tramadol with amlodipine in mice. Indian J Pharmacol. 2013 Jan-Feb;45(1):76-9. doi: 10.4103/0253-7613.106440.

    PMID: 23543914BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • AbdelGany MA Hassan, MRCOG, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Hassan

Study Record Dates

First Submitted

February 16, 2014

First Posted

February 21, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

EG(1)