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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Supportive Care
Condition Laparoscopic Cholecystectomy
Interventions Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"
Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"
Enrollment 67
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title IV Acetaminophen 1000mg + 2 Oral "Sugar Pills" Oral Acetaminophen 2 Capsules + "IV Salt Water"
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 34 33
Completed 28 22
Not Completed 6 11
Reason Not Completed
Lost to Follow-up             5             6
didn't qualify             1             2
pharmacy error             0             1
missed med dose             0             1
Withdrawal by Subject             0             1
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 28 22 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 22 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
 100.0%
22
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 22 participants 50 participants
43.64  (12.13) 37.00  (10.65) 40.32  (11.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 22 participants 50 participants
Female
21
  75.0%
21
  95.5%
42
  84.0%
Male
7
  25.0%
1
   4.5%
8
  16.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 22 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  21.4%
2
   9.1%
8
  16.0%
White
21
  75.0%
16
  72.7%
37
  74.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.6%
4
  18.2%
5
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 22 participants 50 participants
28 22 50
1.Primary Outcome
Title Pain
Hide Description 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.
Time Frame 24 hours after discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times.
A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times. There were no significant differences between the groups over time, Wilks’ Lambda (P = 0.875). (Table 4 and Figure 1)
Overall Number of Participants Analyzed 28 22
Mean (Standard Deviation)
Unit of Measure: NRS scale
pre-op 1.41  (2.09) 1.73  (1.93)
Arrival in PACU 1.61  (2.78) 2.32  (2.73)
Discharge from PACU 2.36  (1.73) 2.64  (1.56)
Discharge+6hrs 4.81  (2.24) 4.81  (1.69)
Discharge+12hrs 5.09  (2.60) 4.71  (2.08)
Discharge+18hrs 4.12  (2.62) 4.21  (2.07)
Discharge+24hrs 3.96  (2.47) 4.09  (1.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.875
Comments [Not Specified]
Method Repeated analysis of variance
Comments [Not Specified]
2.Secondary Outcome
Title Total Opioid Consumption From Time of First Waking to T24
Hide Description

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 Frame every 6 hours for 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
This group consisted of 28 subjects' data that was analyzed. Of the 28 there were 7 males 21 females.
This group consisted of 22 subjects that received the oral acetaminophen and IV placebo. Of the 22 there was 1 male and 21 female.
Overall Number of Participants Analyzed 28 22
Mean (Standard Deviation)
Unit of Measure: milligrams
PACU 13.46  (23.20) 17.41  (17.91)
Home Consumption 36.96  (33.19) 39.56  (37.56)
Total consumption from peration to 24 hrs 153.38  (57.32) 163.86  (78.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.05
Comments [Not Specified]
Method Manova
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description .Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen No adverse events
All-Cause Mortality
Group 1 Group 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/28 (3.57%)      0/22 (0.00%)    
Gastrointestinal disorders     
Hospitalization greater 24 hours  1  1/28 (3.57%)  1 0/22 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/28 (7.14%)      0/22 (0.00%)    
Cardiac disorders     
hospitalizatoin  1 [1]  1/28 (3.57%)  1 0/22 (0.00%)  0
Renal and urinary disorders     
ER visit  1 [2]  1/28 (3.57%)  1 0/22 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
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
[2]
subject came to the ER POD 1 for urinary retention post catheter removal, IRB informed but determined non related. She was sent home again.
Small sample size Only one institution utilized
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Anthony R Plunkett, MD
Organization: Womack Army Medical Center
Phone: 910-907-6000
EMail: anthonyrplunkett@gmail.com
Layout table for additonal information
Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT01823224     History of Changes
Other Study ID Numbers: 380250
First Submitted: March 29, 2013
First Posted: April 4, 2013
Results First Submitted: October 2, 2015
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016