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Phase 4 Completed N=103 Randomized Quadruple-blind Treatment

Determine the Clinical Advantage of IV vs PO Acetaminophen

Source: ClinicalTrials.gov NCT03558555 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: PACU Visual Analogue Pain Scores — 2.13; 1.52; 2.88; 2.41 score on a scale
◆ Published Evidence
Established
21citations · ~4 / year
Comparison of clinical outcomes of acetaminophen IV vs PO in the peri-operative setting for laparoscopic inguinal hernia repair surgeries: A triple-blinded, randomized controlled trial.
Journal of clinical anesthesia · 2020 · High-confidence link

Summary

There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.

Linked Publications

  • Comparison of clinical outcomes of acetaminophen IV vs PO in the peri-operative setting for laparoscopic inguinal hernia repair surgeries: A triple-blinded, randomized controlled trial.
    Journal of clinical anesthesia · 2020 · 21 citations · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
PACU Visual Analogue Pain Scores
2.13; 1.52; 2.88; 2.41; 1.45; 1.59
PRIMARY
Total MME Intraoperatively
63.75; 57.24
PRIMARY
Total Narcotic Use in PACU.
11.33; 9.83
SECONDARY
PACU Length of Stay
82.93; 64.05
SECONDARY
Patient Reported Total Narcotic Use Post-discharge
14.06; 17.56
SECONDARY
Patient Satisfaction.
5.05; 6.20

Eligibility Criteria

Inclusion Criteria

  • ASA scores I-III
  • Ambulatory surgery patients
  • Ages 18-75
  • Surgeries requiring general anesthesia for hernia surgery

Exclusion Criteria

  • Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
  • Known allergy to acetaminophen
  • Emergency surgery
  • Patients who were not fasted
  • Patients who cannot tolerate PO
  • Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
  • Pregnancy
  • Weight less than 50kg
  • Chronic daily narcotic use
  • Patients who's anesthetic plan requires regional anesthesia
  • Patient refusal to participate or do not have capacity to provide consent.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03558555) and the linked publication. 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. Informational only — not medical advice.

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