Phase 4
N=68
Efficacy of IV Acetaminophen for Pain Management
Post-operative Pain
Bottom Line
View on ClinicalTrials.gov: NCT02028715 ↗Enrolled (actual)
68
Serious AEs
4.4%
Results posted
Dec 2018
Primary outcome: Primary: Opioid Rescue - 48 Hours — 54.4803; 48.9253 Milligrams of intravenous morphine equiv — p=.356
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Placebo (Drug); IV acetaminophen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Aultman Health Foundation
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Rescue - 48 Hours |
54.4803; 48.9253 | .356 |
| SECONDARY Return of Bowel Function |
68.0878; 56.5696 | .105 |
| SECONDARY Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge |
4.21; 4.19; 4.08; 4.04; 4.58; 4.23 | .029 sig |
| SECONDARY Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge |
3.88; 3.73; 4.12; 3.50; 4.17; 3.65 | .643 |
| SECONDARY Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge |
3.58; 4.23; 3.75; 3.69; 3.79; 3.35 | .217 |
| SECONDARY Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge |
3.71; 3.58; 3.67; 3.85; 3.54; 3.88 | .647 |
| SECONDARY Length of Stay |
3.62; 3.57 | — |
Summary
The investigators' goal in this planned prospective, randomized, patient blinded study is to compare our standard of care as the control group to an experimental group in which patients receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8 doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will include amount of rescue opioids required, time to return of bowel function, length of hospital stay, and patient satisfaction. The hypothesis is that the addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of associated gastrointestinal side effects including nausea, vomiting, bloating, and constipation. The hope is that it will affect the final outcome of quicker return of bowel function, increased patient satisfaction, shortened hospital stay and prove to be an overall more effective postoperative pain management approach.
Eligibility Criteria
Inclusion Criteria
-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.
Exclusion Criteria
- Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
- Patients with baseline CrCl 85
- Any physical, medical, and mental condition that would make participation in the study inadvisable.
Data sourced from ClinicalTrials.gov (NCT02028715). 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.