Effect of Oral Tramadol Administration Prior to IUD Insertion

Phase 3

• Conditions: Contraception
• Interventions: Drug: Placebo oral tablet; Drug: oral tramadol

• Registration Number: NCT04312061
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-14
• Last Update Submitted: 2020-03-14
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18
• Study Start: 2020-03-30
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo oral tablet	oral placebo tablet given 1 hour before LNG-IUD insertion
oral tramadol	oral tramadol	oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion

Primary Outcome Measures

Name	Time	Method
pain during IUD insertion	5 minutes	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.

Secondary Outcome Measures

Name	Time	Method
duration of the procedure	5 minutes	duration of IUD insertion from speculum in to speculum out in minutes