Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery

Sponsor
University of Puerto Rico
Study ID
NCT07571252
Phase
PHASE4
Status
Recruiting
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Conditions

  • Orthognathic Surgery
  • Post Operative Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Acetaminophen — DRUG
    Acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life.
  • ibuprofen — DRUG
    Ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life.

Study Details

This randomized controlled clinical trial evaluates the effect of preemptive analgesia on postoperative pain outcomes in adult patients undergoing orthognathic surgery. Participants scheduled for bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia will be randomized to one of three groups: intravenous acetaminophen, intravenous ibuprofen, or a control group receiving standard postoperative analgesia without preoperative medication. The study aims to determine whether the administration of pre-surgical analgesics reduces postoperative pain intensity and analgesic requirements during the early postoperative period. Pain will be assessed using a standardized pain scale at multiple time points following surgery, and secondary outcomes will include postoperative analgesic consumption and patient satisfaction with pain control. This investigation seeks to contribute evidence supporting multimodal analgesic strategies and improved postoperative pain management in patients undergoing orthognathic surgery.

Key Dates

First listed
May 6, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous Acetaminophen
    Participants randomized to this arm will receive acetaminophen 1 g administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the surgical procedure according to the medication half-life. Postoperative pain outcomes will be compared with the other study groups.
  • Experimental: Intravenous Ibuprofen
    Participants randomized to this arm will receive ibuprofen 600 mg administered intravenously approximately 30 minutes prior to surgical incision during orthognathic surgery under general anesthesia. A second dose will be administered near the end of the procedure according to the medication half-life. Postoperative pain outcomes will be compared with the other study groups.
  • No Intervention: Standard Care Control
    Participants randomized to this arm will not receive preoperative analgesic medication. Postoperative pain management will follow the institution's standard care protocol after completion of the surgical procedure. Outcomes will be compared with participants receiving preemptive intravenous analgesic interventions.

Primary Outcome Measure

Postoperative Pain Intensity [ Time Frame: 1 hour, 4 hours, and 24 hours after surgery ]

Central Contacts

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