NCT02827487

Brief Summary

Two hundred and ten women requesting IUD insertion 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 (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) 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. After insertion of the IUD the women's pain perception will be assessed using a visual analogue scale (VAS) graduated from zero to 10 with zero corresponding to no pain and 10 corresponding to the worst possible pain.

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 P75+ for phase_4 pain

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_4 pain

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

July 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

4 years

First QC Date

July 3, 2016

Last Update Submit

April 4, 2019

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Pain after IUD insertion

    Women will mark a point corresponding to their pain on a visual analogue scale

    one minute after IUD insertion

Study Arms (3)

Tramadol

ACTIVE COMPARATOR

Women will receive oral Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) and an oral placebo similar to Celecoxib 2 hours before IUD insertion.

Drug: TramadolDrug: Placebo 2Procedure: IUD

Celecoxib

ACTIVE COMPARATOR

Women will receive oral Celecoxib 200mg (Celebrex® 200, Pfizer, USA) and an oral placebo similar to Tramadol 2 hours before IUD insertion.

Drug: CelecoxibDrug: Placebo 1Procedure: IUD

Placebo 1

PLACEBO COMPARATOR

Women will receive a placebo similar to Tramadol and a placebo similar to Celecoxib orally 2 hours before IUD insertion.

Drug: Placebo 1Drug: Placebo 2Procedure: IUD

Interventions

TramadolDRUG

Women will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally 2 hours before IUD insertion.

Tramadol
CelecoxibDRUG

Women will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) orally 2 hours before IUD insertion.

Celecoxib
Placebo 1DRUG

Women will receive a placebo similar to Tramadol orally 2 hours before IUD insertion.

CelecoxibPlacebo 1
Placebo 2DRUG

Women will receive a placebo similar to Celecoxib orally 2 hours before IUD insertion.

Placebo 1Tramadol
IUDPROCEDURE

IUD insertion

CelecoxibPlacebo 1Tramadol

Eligibility Criteria

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

You may qualify if:

  • Women with expected difficult IUD insertion like nulliparous women and women with previous cesarean section.

You may not qualify if:

  • Previous vaginal delivery.
  • Submucous myoma.
  • Uterine anomalies.
  • Undiagnosed vaginal bleeding.
  • Pelvic inflammatory disease.

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

  • Kass-Wolff JH, Fisher JE. Evidence-based pain management for endometrial biopsies and IUD insertions. Nurse Pract. 2014 Mar 13;39(3):43-50. doi: 10.1097/01.NPR.0000434094.19101.d1.

    PMID: 24535311BACKGROUND

  • Scavuzzi A, Souza AS, Costa AA, Amorim MM. Misoprostol prior to inserting an intrauterine device in nulligravidas: a randomized clinical trial. Hum Reprod. 2013 Aug;28(8):2118-25. doi: 10.1093/humrep/det240. Epub 2013 Jun 5.

    PMID: 23739219BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

TramadolCelecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsBenzenesulfonamidesSulfonamidesAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • AbdelGany M Hassan

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AbdelGany M Hassan, MRCOG, MD

CONTACT

1017801604abdelgany2@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
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

July 3, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

EG(1)