Conditions: Contraception Pain
Keywords: naproxen lidocaine intrauterine device IUD pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: yes

Brief summary:
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.

Detailed description:
This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.

The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.

Arms:
arm 1: Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion arm 2: Patient will receive naproxen and intrauterine normal saline prior to IUD insertion arm 3: Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion arm 4: Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion

Interventions: intervention 1: Naproxen intervention 2: Lidocaine intervention 3: placebo
Intervention descriptions: intervention 1: Oral naproxen vs placebo intervention 2: Intrauterine lidocaine vs normal saline intervention 3: either normal saline or empty oral capsule

Protocol document: