Title
Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,
A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy
Phase
N/AStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Laparoscopic CholecystectomyIntervention/Treatment
acetaminophen ...Study Participants
67The 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.
Subjects were enrolled following the listed inclusion and exclusion criteria.
Subjects Eligibility Criteria:
Inclusion Criteria:
Male and female patients ASA I - III . 18 years of age and older
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) Previous Bowel resection, colon surgery, stomach surgery
. 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;
Taking a medication with known interactions with acetaminophen
Taking 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)
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 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.
Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules "sugar pills" 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg
Group 2 will receive an IV "salt water" infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.
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)
| Event Type | Organ System | Event Term | Group 1 | Group 2 |
|---|
Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain.
Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded: Opioid consumption from first waking to T4 Total opioid consumption from T0 to T4 Total opioid consumption from time of first waking to T24
