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Phase 4 N=120 Randomized Quadruple-blind Treatment

Preoperative IV Versus Oral Acetaminophen

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT03468920 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Patient Reported Pain — 4.12; 4.37 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
IV Acetaminophen (Drug); PO Acetaminophen (Drug); PO Placebo (Drug); IV Solution Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
TriHealth Inc.
Primary completion
Feb 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Reported Pain		 4.12; 4.37 —
SECONDARY
Number of Participants Who Received Opioid Administration in PACU		 31; 34 —
SECONDARY
Number of Participants Who Experienced Postoperative Nausea and Vomiting		 8; 6 —
SECONDARY
Length of Stay		 88.25; 92.88 —
SECONDARY
Patient Satisfaction		 9.45; 9.77 —

Summary

The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.

Eligibility Criteria

Inclusion Criteria

  • 18 years old or older
  • Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia

Exclusion Criteria

  • Allergy to Acetaminophen
  • Lactose intolerance or lactose allergy (placebo capsules contain lactose)
  • Hepatic disease
  • Having taken a product containing acetaminophen within 6 hours of scheduled surgery time
  • Pregnant
  • Weight less than 50kg
  • Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse
  • Emergent or on-call procedures
  • Inpatient surgery
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03468920). 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.

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