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Effect of Oral Tramadol Administration Prior to IUD Insertion

NCT ID: NCT04312061

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-30

Study Completion Date

2020-07-05

Brief Summary

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the aim of the study is to evaluate the safety and efficacy of oral tramadol administration in reducing pain during LNG- IUD insertion in adolescents and young women

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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oral tramadol

oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion

Group Type EXPERIMENTAL

oral tramadol

Intervention Type DRUG

oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion

placebo

oral placebo tablet given 1 hour before LNG-IUD insertion

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

oral placebo tablet given 1 hour before LNG-IUD insertion

Interventions

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oral tramadol

oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion

Intervention Type DRUG

Placebo oral tablet

oral placebo tablet given 1 hour before LNG-IUD insertion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* nulliparous adolescents and young women requesting LNG-IUD insertion

Exclusion Criteria

* parous women, contraindications to LNG-IUD insertion and allergy or contraindications to tramadol
Minimum Eligible Age

14 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

assistant professor obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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AHMED SAMY

Role: CONTACT

[email protected]
+201100681167

Other Identifiers

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tramadol IUD

Identifier Type: -

Identifier Source: org_study_id

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