Trial Outcomes & Findings for Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control, (NCT NCT01823224)

Last Updated: 2016-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

67 participants

Primary outcome timeframe

24 hours after discharge

Results posted on

2016-06-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	34	33
Overall Study COMPLETED	28	22
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	5	6
Overall Study didn't qualify	1	2
Overall Study pharmacy error	0	1
Overall Study missed med dose	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=28 Participants 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 n=22 Participants 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 n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.64 years STANDARD_DEVIATION 12.13 • n=5 Participants	37.00 years STANDARD_DEVIATION 10.65 • n=7 Participants	40.32 years STANDARD_DEVIATION 11.39 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	22 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after discharge

Outcome measures

Outcome measures
Measure	Group 1 n=28 Participants 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.	Group 2 n=22 Participants 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)
Pain pre-op	1.41 NRS scale Standard Deviation 2.09	1.73 NRS scale Standard Deviation 1.93
Pain Arrival in PACU	1.61 NRS scale Standard Deviation 2.78	2.32 NRS scale Standard Deviation 2.73
Pain Discharge from PACU	2.36 NRS scale Standard Deviation 1.73	2.64 NRS scale Standard Deviation 1.56
Pain Discharge+6hrs	4.81 NRS scale Standard Deviation 2.24	4.81 NRS scale Standard Deviation 1.69
Pain Discharge+12hrs	5.09 NRS scale Standard Deviation 2.60	4.71 NRS scale Standard Deviation 2.08
Pain Discharge+18hrs	4.12 NRS scale Standard Deviation 2.62	4.21 NRS scale Standard Deviation 2.07
Pain Discharge+24hrs	3.96 NRS scale Standard Deviation 2.47	4.09 NRS scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Group 1 n=28 Participants 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.	Group 2 n=22 Participants 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)
Total Opioid Consumption From Time of First Waking to T24 PACU	13.46 milligrams Standard Deviation 23.20	17.41 milligrams Standard Deviation 17.91
Total Opioid Consumption From Time of First Waking to T24 Home Consumption	36.96 milligrams Standard Deviation 33.19	39.56 milligrams Standard Deviation 37.56
Total Opioid Consumption From Time of First Waking to T24 Total consumption from peration to 24 hrs	153.38 milligrams Standard Deviation 57.32	163.86 milligrams Standard Deviation 78.04

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=28 participants at risk .Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen	Group 2 n=22 participants at risk No adverse events
Gastrointestinal disorders Hospitalization greater 24 hours	3.6% 1/28 • Number of events 1 • 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.	0.00% 0/22 • 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.

Other adverse events

Other adverse events
Measure	Group 1 n=28 participants at risk .Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen	Group 2 n=22 participants at risk No adverse events
Cardiac disorders hospitalizatoin	3.6% 1/28 • Number of events 1 • 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.	0.00% 0/22 • 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.
Renal and urinary disorders ER visit	3.6% 1/28 • Number of events 1 • 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.	0.00% 0/22 • 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.

Additional Information

Anthony R Plunkett, MD

Womack Army Medical Center

Phone: 910-907-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place