Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Infertility Female
  • Pain Postoperative
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 44 years
Gender
Only males

Description

OBJECTIVE: To compare the efficacy of pre-operative IV acetaminophen, PO acetaminophen, versus placebo for adjunctive pain control in the setting of oocyte retrieval in an in vitro fertilization clinic setting. HYPOTHESIS: Our hypothesis is that patients receiving IV acetaminophen pre-operatively wi...

OBJECTIVE: To compare the efficacy of pre-operative IV acetaminophen, PO acetaminophen, versus placebo for adjunctive pain control in the setting of oocyte retrieval in an in vitro fertilization clinic setting. HYPOTHESIS: Our hypothesis is that patients receiving IV acetaminophen pre-operatively will have improved postoperative pain scores, lower overall opiate consumption, and shortened time to discharge from PACU than those receiving PO acetaminophen or placebo. Participants will be consented and enrolled in the study prior to their oocyte retrieval. The patient will then be randomized to one of three treatments: Group 1: In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed. Group 2: In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed. Group 3: In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. The patient and care team will be blinded to the treatment group. A member of the study staff will review participants' medical record to collect data regarding demographics, clinical history, cycle and pregnancy outcomes, up to 12 months following study completion.

Tracking Information

NCT #
NCT03073980
Collaborators
Not Provided
Investigators
Principal Investigator: John C Petrozza, MD Massachusetts General Hospital