Effect of Oral Tramadol Administration Prior to IUD Insertion

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Contraception

Treatments: Drug: oral tramadol; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04312061

tramadol IUD

Details and patient eligibility

About

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

Enrollment: 108 estimated patients

Sex: Female

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

108 participants in 2 patient groups, including a placebo group

oral tramadol

Experimental group

Description:

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

Treatment:

Drug: oral tramadol

placebo

Placebo Comparator group

Description:

oral placebo tablet given 1 hour before LNG-IUD insertion

Treatment:

Drug: Placebo oral tablet