Effect of Oral Tramadol Administration Prior to IUD Insertion

Phase 3UnknownNCT04312061

Cairo University108 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

108

Conditions

Contraception

Interventions

oral tramadolDRUG

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

Placebo oral tabletDRUG

oral placebo tablet given 1 hour before LNG-IUD insertion

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

pain during IUD insertion

intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 10 on a 10 cm horizontal straight line, where 'zero' corresponds to no pain at all, and '10' to the worst possible pain imaginable.

Time frame: 5 minutes

Secondary Outcomes

duration of the procedure

duration of IUD insertion from speculum in to speculum out in minutes

Time frame: 5 minutes

Central Contacts

AHMED SAMY

CONTACT

+201100681167 ahmedsamy8233@gmail.com

Data from ClinicalTrials.gov

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