CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 71 enrolled
Drug / intervention
Ibuprofen 400 mg +1 moredrug
Likely dose
Ibuprofen 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06478758
NCT06478758Phase 4Completed

Ibuprofen Use on Post-operative Pain Following Cholecystectomy

Giresun University·interventional·Posted Jun 27, 2024·Updated Jun 27, 2024

In Brief

A Phase 4 clinical trial evaluating Ibuprofen 400 mg and Acetaminophen 100 MG/ML for Acute Post-operative Pain. Completed, enrolled 71 participants across 1 site.

Detailed Summary

In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedJun 27, 2024
Enrollment StartFeb 1, 2024
Primary CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.0 years ago

Interventions

Ibuprofen 400 mgdrug

The ibuprofen group (n=36) was administered 800 mg of ibuprofen . All procedures were performed with the same team. During surgery, a 20% increase in the participant's heart rate and mean arterial pressure remifentanil infusion was administered. During the postoperative period, all participants continued to receive acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4. In the recovery room, the participants with a visual analog score of \> 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of \> 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded.

Acetaminophen 100 MG/MLdrug

The investigators administered 1000 mg of acetaminophen to the participants in Group A. A 20% increase in the participant's heart rate and mean arterial pressure was evaluated as pain and remifentanil infusion was administered. All participants continued to receive the routine application of acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4, postoperatively.In the recovery room, participants with a visual analog score of \> 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of \> 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded.