Phase 4
N=110
Efficacy of Oral vs. Intravenous Acetaminophen
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT02643394 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain) — 2; 2 units on a scale — p=0.252
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral Acetaminophen (Drug); Intravenous acetaminophen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain) |
2; 2 | 0.252 |
| SECONDARY Morphine Equivalents of Postoperative Opioid Usage |
5; 5 | 0.402 |
Summary
The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown. In this observer blinded randomized clinical trial, investigators aim to determine the comparative efficacy of PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.
Eligibility Criteria
Inclusion Criteria
- Adult patients aged 18 years or older
- Undergoing elective sinus surgery at Zale Lipshy Hospital
Exclusion Criteria
- Inability of the patient to follow directions or comprehend either English or Spanish language.
- Disorders of the liver which would make acetaminophen contraindicated (such as hepatitis, liver failure, prior liver transplant, etc).
- Patients with chronic pain manifest by a baseline pain score > 4/10
- Chronic opioid use (>2 weeks continuously), or illicit drug abuse
- Body weight < 50 kg.
- Patients with contraindications to any of the study drugs (such as Malignant Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
- Patients who have taken analgesic medications on the morning of surgery (prior to arrival).
- Allergy to acetaminophen
Data sourced from ClinicalTrials.gov (NCT02643394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.