NCT02714231

Brief Summary

The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4

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

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

March 14, 2016

Last Update Submit

July 15, 2017

Conditions

Family Planning

Outcome Measures

Primary Outcomes (1)

  • Mean pain score during insertion

    intraoperative

Secondary Outcomes (1)

  • Patient satisfaction score

    5 minutes

Study Arms (2)

diclofenac

EXPERIMENTAL

oral diclofuhenac sodium

Drug: diclofenac sodium (cataflam)

hyoscine

ACTIVE COMPARATOR

oral hyoscine butyl bromide

Drug: hyoscine butyl bromide (buscopan)

Interventions

diclofenac sodium (cataflam)DRUG

The patients in the study group will take one tablet of cataflam 50 mg 30 min before the scheduled time of the procedure

diclofenac
hyoscine butyl bromide (buscopan)DRUG

The patients in the study group will take one tablet of buscopan 10 mg 30 min before the scheduled time of the procedure

hyoscine

Eligibility Criteria

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

You may qualify if:

  • Women not taken analgesics or anxiolytics in the 24 hours prior insertion
  • Women not taken misoprostol prior to intrauterine device insertion
  • Women who will accept to participate in the study

You may not qualify if:

  • Any contraindication to intrauterine device placement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

DiclofenacButylscopolammonium Bromide

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsQuaternary Ammonium CompoundsAminesScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • ahmed abbas, MD

    Woman health hospital Assiut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 21, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Locations

EG(1)