Effect of Oral Tramadol Administration Prior to IUD Insertion

Contraception Clinical Trial

Official title:

Safety and Efficacy of Oral Tramadol Administration in Reducing Pain During Levonorgestrel Intrauterine Device Insertion in Adolescents and Young Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04312061
• Other study ID #: tramadol IUD
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 30, 2020
• Est. completion date: July 5, 2020

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: AHMED SAMY
• Phone: +201100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: July 5, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• oral tramadol
oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion
• Placebo oral tablet
oral placebo tablet given 1 hour before LNG-IUD insertion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes
Secondary	duration of the procedure	duration of IUD insertion from speculum in to speculum out in minutes	5 minutes