Phase 4
Completed N=126
Time of Intravenous Acetaminophen Administration
Source: ClinicalTrials.gov NCT01699815 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Changes in Postoperative Pain Scores — 2.7; 2.5; 0.9; 1.5 units on a scale
Summary
The purpose of the study is to examine the effects of timing of administration of intravenous (IV) acetaminophen and how timing relates to analgesic efficacy as measured by postoperative pain scores. A maximum of 138 patients meeting inclusion criteria who present for a scheduled total hip replacement under general anesthesia will be randomized into one of two arms: 1) the pre-closure group will receive the first dose administered upon onset of skin closure, 2) the preemptive group will receive the first dose administered within 60 minutes prior to incision. Both groups will receive subsequent doses every 6 hours x 24 hours.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Postoperative Pain Scores |
2.7; 2.5; 0.9; 1.5; 2.6; 2.6 | — |
| SECONDARY Pain Medication Consumption Rates |
50; 42 | — |
Eligibility Criteria
Inclusion Criteria
- Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip arthroplasty performed under general anesthesia will be included. As determined by the anesthesia team assigned to the case, eligible patients will also be assigned ASA physical status of I, II, or III and deemed capable of reporting their perceived pain using numeric pain scales and capable of operating a patient controlled anesthesia (PCA) device.
Exclusion Criteria
- Exclusion criteria include known allergy, hypersensitivity, or contraindication to acetaminophen, history of alcohol or drug abuse, prisoners, emergency THAs, patients with chronic malnutrition or a body mass index (BMI) 2.0 mg/dl).
Data sourced from ClinicalTrials.gov (NCT01699815). 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.