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

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ClinicalTrials.gov Identifier: NCT01823224
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management

Tracking Information
First Submitted Date  ICMJE March 29, 2013
First Posted Date  ICMJE April 4, 2013
Results First Submitted Date  ICMJE October 2, 2015
Results First Posted Date  ICMJE June 6, 2016
Last Update Posted Date June 6, 2016
Study Start Date  ICMJE February 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
Pain [ Time Frame: 24 hours after discharge ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
Pain [ Time Frame: 24 hours after discharge ]
Pain after treatment with IV versus oral tylenol will be assessed via pain scores
Change History Complete list of historical versions of study NCT01823224 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
Total Opioid Consumption From Time of First Waking to T24 [ Time Frame: every 6 hours for 24 hours ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
Opioid Use [ Time Frame: every 6 hours for 24 hours ]
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
  • Time to first use of rescue medication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,
Official Title  ICMJE A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy
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.
Detailed Description

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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Laparoscopic Cholecystectomy
Intervention  ICMJE
  • Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"
    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.
    Other Name: Acetaminophen is comercially referred to as Tylenol.
  • Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"
    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.
    Other Name: Acetaminophen is comercially referred to as Tylenol.
Study Arms  ICMJE
  • Experimental: Group 1
    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
    Intervention: Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"
  • Experimental: Group 2
    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.
    Intervention: Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2016)
67
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2013)
220
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01823224
Other Study ID Numbers  ICMJE 380250
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Defense and Veterans Center for Integrative Pain Management
Study Sponsor  ICMJE Defense and Veterans Center for Integrative Pain Management
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony R Plunkett, MD Womack Army Medical Center
PRS Account Defense and Veterans Center for Integrative Pain Management
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP