CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
2 capsules Oral Tylenol 2000 mg and IV "salt water" +1 moredrug
Likely dose
2 capsules Oral Tylenol 2000 mg and IV "salt water"from 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/NCT01823224
NCT01823224N/ACompleted

A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

Defense and Veterans Center for Integrative Pain Management·interventional·Posted Apr 4, 2013·Updated Jun 6, 2016

In Brief

A clinical study evaluating 2 capsules Oral Tylenol 2000 mg and IV "salt water" and IV tylenol 1000mg and 2 oral capsule "sugar pills" for Laparoscopic Cholecystectomy. Completed, enrolled 67 participants across 1 site.

Detailed Summary

The purpose of the study is to learn whether perioperative IV (intravenous) administration of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen, it may result in fewer requests for pain-related intervention such as other oral pain medications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2013
Enrollment StartFeb 1, 2013
Primary CompletionJun 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 13.2 years ago

Interventions

2 capsules Oral Tylenol 2000 mg and IV "salt water"drug

The participants randomized to receive the '2 capsules Oral Acetaminophen 500 mg and IV "salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly.

IV tylenol 1000mg and 2 oral capsule "sugar pills"drug

IV acetaminophen 1000mg and 2 oral capsule "sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group.