NCT02736071

Brief Summary

Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
210

participants targeted

Target at P25-P50 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

First Submitted

Initial submission to the registry

April 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

April 8, 2016

Last Update Submit

July 3, 2016

Conditions

Hysteroscopy

Outcome Measures

Primary Outcomes (1)

  • Pain perception during the procedure

    A nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain

    5 minutes after starting the procedure

Secondary Outcomes (1)

  • Pain perception after the procedure

    30 minutes after completing the procedure

Study Arms (3)

Celecoxib

ACTIVE COMPARATOR

Women will receive oral Celecoxib 200mg 2 hours before the procedure

Drug: Celecoxib

Tramadol

ACTIVE COMPARATOR

Women will receive oral Tramadol 100 mg 2 hours before the procedure

Drug: Tramadol

Placebo

PLACEBO COMPARATOR

Women will receive an oral placebo similar to Tramadol and an oral placebo similar to Celecoxib 2 hours before the procedure

Drug: Placebo 1Drug: Placebo 2

Interventions

CelecoxibDRUG

Women will receive oral Celecoxib 200mg 2 hours before the procedure

Celecoxib
TramadolDRUG

Women will receive oral Tramadol 100mg 2 hours before the procedure

Tramadol
Placebo 1DRUG

Women will receive an oral placebo similar to Tramadol 2 hours before the procedure

Placebo
Placebo 2DRUG

Women will receive an oral placebo similar to Celecoxib 2 hours before the procedure

Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Indication for operative outpatient hysteroscopy, indications will include endometrial biopsy, polypectomy, septum resection, intra-uterine device removal and adhesiolysis.

You may not qualify if:

  • Submucous myomas.
  • Known medical disorders like uncontrolled diabetes, hypertension, cardiac, renal or liver disease.
  • Gastritis or peptic ulcer.
  • Allergy to Tramadol or Celecoxib.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

RECRUITING

Related Publications (3)

  • Hassan A, Wahba A, Haggag H. Tramadol versus Celecoxib for reducing pain associated with outpatient hysteroscopy: a randomized double-blind placebo-controlled trial. Hum Reprod. 2016 Jan;31(1):60-6. doi: 10.1093/humrep/dev291. Epub 2015 Nov 29.

    PMID: 26621854BACKGROUND

  • 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

Interventions

CelecoxibTramadol

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesAminesLipids

Study Officials

  • AbdelGany M Hassan, MRCOG, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AbdelGany M Hassan, MRCOG, MD

CONTACT

+201017801604abdelgany2@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
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 8, 2016

First Posted

April 13, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)