Preemptive pain relief for jaw surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, participant-blinded trial, adults aged 21–65 undergoing bilateral sagittal split osteotomy and Le Fort I osteotomy will be assigned to receive intravenous acetaminophen, intravenous ibuprofen, or no preoperative analgesia. A pre-surgical dose is given about 30 minutes before incision, with a second dose as appropriate, and postoperative pain is measured at multiple time points along with analgesic use and satisfaction. The trial aims to determine if preemptive analgesia can lessen pain and reduce analgesic needs after surgery, contributing to multimodal pain management strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 21 to 65 years.
* American Society of Anesthesiologists (ASA) physical status I or II.
* Scheduled to undergo orthognathic surgery including bilateral sagittal split osteotomy and Le Fort I osteotomy under general anesthesia.
* Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Known allergy or intolerance to acetaminophen, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs).
* Renal dysfunction, defined as estimated glomerular filtration rate \<60 mL/min/1.73 m².
* Hepatic dysfunction, defined as liver enzyme levels greater than twice the upper limit of normal.
* History of bleeding disorders or coagulopathy.
* Active or recent peptic ulcer disease.
* Current use of recreational drugs, including cannabis, that in the judgment of the investigators could interfere with anesthesia management, postoperative pain assessment, or study outcomes.
* Any medical condition that, in the judgment of the investigators, would make participation unsafe or interfere with study participation.

Where it's running

• Administración de Servicios Médicos (ASEM)
  San Juan, Puerto Rico Recruiting

Study contacts

• Study coordinator: Dennys Rivera Pérez, MD
• Email: dennys.rivera@upr.edu
• Phone: 7877582525

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.