Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,

NCT01823224 | Completed Results

• 1 other identifier: 380250
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Pain

  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.

  24 hours after discharge

Secondary Outcomes (1)

• Total Opioid Consumption From Time of First Waking to T24

  every 6 hours for 24 hours

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"

Group 2

EXPERIMENTAL

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.

Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"

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.

Also known as: Acetaminophen is comercially referred to as Tylenol.

Group 2

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.

Also known as: Acetaminophen is comercially referred to as Tylenol.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead

Study Sites (1)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Small sample size Only one institution utilized

Results Point of Contact

• Title: Anthony R Plunkett, MD
• Organization: Womack Army Medical Center

anthonyrplunkett@gmail.com

910-907-6000

Study Officials

• Anthony R Plunkett, MD

  Womack Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 4, 2013
• Study Start: February 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)