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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption From Time of First Waking to T24 | Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded:
| every 6 hours for 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony R Plunkett, MD | Womack Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womack Army Medical Center | Fort Bragg | North Carolina | 28310 | United States |
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Adult patients (male and non-pregnant females, 18 years of age or older) with symptomatic cholelithiasis and ASA rating of I-III scheduled to undergo elective LapChole were eligible for this trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Acetaminophen 1000mg + 2 Oral "Sugar Pills" | 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 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
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| FG001 | Oral Acetaminophen 2 Capsules + "IV Salt Water" | 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. 2 capsules Oral Tylenol 2000 mg and IV "salt water": The participants randomized to receive the '2 capsules Oral Acetaminophenl 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| BG001 | 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. 2 capsules Oral Tylenol 2000 mg and IV "salt water": The participants randomized to receive the '2 capsules Oral Acetaminophenl 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Posted | Mean | Standard Deviation | NRS scale | 24 hours after discharge |
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| Secondary | Total Opioid Consumption From Time of First Waking to T24 | Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded:
| Posted | Mean | Standard Deviation | milligrams | every 6 hours for 24 hours |
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The adverse event data was collected over the course of the subjects hospital stay starting with the time the subject received his first dose of acetaminophen.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | .Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen | 1 | 28 | 2 | 28 | ||
| EG001 | Group 2 | No adverse events | 0 | 22 | 0 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization greater 24 hours | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalizatoin | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | This subject had a planned admit and was in greater than 24 hours after the surgery, she had a cardiac history and was kept as a precaution |
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| ER visit | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | subject came to the ER POD 1 for urinary retention post catheter removal, IRB informed but determined non related. She was sent home again. |
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Small sample size Only one institution utilized
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony R Plunkett, MD | Womack Army Medical Center | 910-907-6000 | anthonyrplunkett@gmail.com |
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Discharge from PACU |
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| Discharge+6hrs |
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| Discharge+12hrs |
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| Discharge+18hrs |
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| Discharge+24hrs |
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