drugset / Trial / NCT03987022
ICE-T Pain Regimen for Total Laparoscopic Hysterectomy
RandomizedParallel-groupOpen-labelOther
Summary
The purpose of this randomized controlled trial is to determine whether, "ICE-T," a multimodal postoperative pain regimen composed of around the clock ice packs, toradol, and tylenol, has improved pain control compared to the standard narcotic based postoperative pain regimen in patients undergoing total laparoscopic gyn surgery.
Timeline
- Start
- 2019-08-01
- Primary completion
- 2022-04-25
- Completion
- 2022-04-25
Outcome
Missed primary endpoint
registry analysis (superiority test); STANDARD Postoperative Regimen; p = .16; Wilcoxon (Mann-Whitney) NCT03987022 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 1 g | Oral |
| Comparator | Ibuprofen | Small molecule | 600 mg | Oral |
| Subject | Ketorolac | Other / unclassified | 30 mg | Intravenous |
| Subject | Oxycodone | Other / unclassified | — | — |
| Comparator | Percocet | Unknown | — | Oral |
| Background | Dilaudid Injectable Product | Unknown | 0.2 mg | Intravenous |
Indications
No indication recorded.