N/A
N=67
Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,
Laparoscopic Cholecystectomy
Bottom Line
View on ClinicalTrials.gov: NCT01823224 ↗Enrolled (actual)
67
Serious AEs
2.0%
Results posted
Jun 2016
Primary outcome: Primary: Pain — 1.41; 1.73; 1.61; 2.32 NRS scale — p=0.875
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 2 capsules Oral Tylenol 2000 mg and IV "salt water" (Drug); IV tylenol 1000mg and 2 oral capsule "sugar pills" (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Defense and Veterans Center for Integrative Pain Management
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain |
1.41; 1.73; 1.61; 2.32; 2.36; 2.64 | 0.875 |
| SECONDARY Total Opioid Consumption From Time of First Waking to T24 |
13.46; 17.41; 36.96; 39.56; 153.38; 163.86 | > 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- Male and female patients ASA I - III (A system used by anesthesiologists to stratify severity of patients' underlying disease and potential for suffering complications from general anesthesia ), 18 years of age and older
- Patient must be scheduled for laparoscopic cholecystectomy
Exclusion Criteria
- Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery
- Chronic home narcotic use (patient-reported narcotic use for greater than 3 months)
- Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery
- Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery
- Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery)
- Prior NSAIDS(Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours
- Use of intraoperative NSAIDs
- Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components;
- On a medication with known interactions with acetaminophen
- On chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day
- Pregnancy
- Current or past alcohol abuse (within the past 2 years)
Data sourced from ClinicalTrials.gov (NCT01823224). 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.