Trial Outcomes & Findings for Effect IV Ibuprofen and Inflammatory Responses (NCT NCT01938040)
NCT ID: NCT01938040
Last Updated: 2016-12-21
Results Overview
Serum concentration of cortisol, CRP, drawn in Post Anesthesia Care unit at 2 hours following surgery were compared with those same levels drawn preoperatively and intraoperatively.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
2 hours following end of surgery
Results posted on
2016-12-21
Participant Flow
60 patients were recruited from the Same Day Surgery Unit at three hospital locations. The dates of recruitment were from 12/1/2011 to 10/2/13.
Of the 60 patients randomized 5 did not receive study medication. The surgical case was either cancelled or the subjects withdrew consent.
Participant milestones
| Measure |
Caldolor/Ibuprofen
800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
|
Placebo
100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
Plasma Analysis
|
24
|
25
|
|
Overall Study
Behavior Metrics
|
28
|
27
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect IV Ibuprofen and Inflammatory Responses
Baseline characteristics by cohort
| Measure |
Ibuprofen/Caldolor
n=28 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=27 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
Total
n=55 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
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Gender
Female
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Gender
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
27 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours following end of surgerySerum concentration of cortisol, CRP, drawn in Post Anesthesia Care unit at 2 hours following surgery were compared with those same levels drawn preoperatively and intraoperatively.
Outcome measures
| Measure |
Ibuprofen/Caldolor
n=24 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=25 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP)
cortisol-PACU
|
173.6 pg/mL
Standard Deviation 29.5
|
289.5 pg/mL
Standard Deviation 25.9
|
|
Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP)
CRP-PACU
|
17 pg/mL
Standard Deviation 1
|
17 pg/mL
Standard Deviation 1
|
SECONDARY outcome
Timeframe: 2 hours postoperatively in PACUOutcome measures
| Measure |
Ibuprofen/Caldolor
n=24 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=25 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Immune Response IL-6
IL-6 PACU
|
8.3 pg/mL
Interval 0.9 to 80.4
|
7.7 pg/mL
Interval 0.5 to 59.1
|
|
Immune Response IL-6
IL-6 preoperatively
|
1.4 pg/mL
Interval 0.3 to 22.2
|
1.2 pg/mL
Interval 0.4 to 14.5
|
|
Immune Response IL-6
IL-6 intraoperatively
|
1.9 pg/mL
Interval 0.4 to 56.4
|
1.1 pg/mL
Interval 0.3 to 22.7
|
SECONDARY outcome
Timeframe: preoperatively and -postoperative days 1 and 3Quality of Recovery-40 has been used to assess postoperative recovery from anesthesia where higher score correlate with improved recovery and well being. The survey has 5 domains: comfort scale ranges 1-60 with higher value indicating greater comfort, emotions scale ranges 1-45 with higher value indicating best emotional state, physical independence scale ranges 1-25 with higher value indicating best independence, patient support scale ranges 1-35 with a higher score indicating greater support and pain scale 1-35 with higher number indicating greater relief from pain. Scoring is done for PART A on a scale of 1-5 (1=very poor=none of the time, worst score, 5=excellent=all of the time, best possible score).PART B on a scale of 1-5 (1=very poor or all the time worse score), 5=excellent or none of the time, best score) Perfect score=200.
Outcome measures
| Measure |
Ibuprofen/Caldolor
n=28 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=27 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Quality of Recovery-40
preop comfort
|
56.5 units on a scale
Standard Deviation 5.69
|
56.8 units on a scale
Standard Deviation 5.12
|
|
Quality of Recovery-40
Preop emotion
|
42.9 units on a scale
Standard Deviation 3.7
|
43 units on a scale
Standard Deviation 3.3
|
|
Quality of Recovery-40
Preop phy indep
|
24.8 units on a scale
Standard Deviation 0.7
|
24.6 units on a scale
Standard Deviation 1.6
|
|
Quality of Recovery-40
preop support
|
34.9 units on a scale
Standard Deviation 0.19
|
34.5 units on a scale
Standard Deviation 1.4
|
|
Quality of Recovery-40
preop pain
|
34 units on a scale
Standard Deviation 1.3
|
33.7 units on a scale
Standard Deviation 1.6
|
|
Quality of Recovery-40
POD #1 comfort
|
58. units on a scale
Standard Deviation 2.72
|
51.2 units on a scale
Standard Deviation 8.6
|
|
Quality of Recovery-40
POD #1 emotion
|
44.4 units on a scale
Standard Deviation 1.3
|
40.4 units on a scale
Standard Deviation 4.1
|
|
Quality of Recovery-40
POD #1phy ind
|
33.8 units on a scale
Standard Deviation 5.7
|
23.5 units on a scale
Standard Deviation 3.0
|
|
Quality of Recovery-40
POD #1 support
|
33.6 units on a scale
Standard Deviation 5.7
|
34.2 units on a scale
Standard Deviation 3.0
|
|
Quality of Recovery-40
POD# 1 pain
|
33.6 units on a scale
Standard Deviation 1.8
|
27 units on a scale
Standard Deviation 7.4
|
|
Quality of Recovery-40
POD#3 comfort
|
59.4 units on a scale
Standard Deviation 0.9
|
55 units on a scale
Standard Deviation 4.7
|
|
Quality of Recovery-40
POD #3 emotion
|
44.8 units on a scale
Standard Deviation 0.6
|
43 units on a scale
Standard Deviation 2.9
|
|
Quality of Recovery-40
POD#3 phy ind
|
24.7 units on a scale
Standard Deviation 0.8
|
24 units on a scale
Standard Deviation 1.6
|
|
Quality of Recovery-40
POD#3 support
|
34.8 units on a scale
Standard Deviation 0.9
|
33.6 units on a scale
Standard Deviation 4.2
|
|
Quality of Recovery-40
POD#3 pain
|
34.5 units on a scale
Standard Deviation 0.75
|
30.4 units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: preoperative-postoperative day 1 and day 3This questionnaire contains 9 statements that rate severity of fatigue symptoms. Score 1 indicates strong disagreement with the statement and 7= strong agreement. i.e (I am easily fatigued).Total lowest possible score indicating no fatigue is 9. Total highest possible score is 63 which correlates to severe fatigue, interfering with all activities of daily living.
Outcome measures
| Measure |
Ibuprofen/Caldolor
n=28 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=27 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Modified Fatigue Severity Scale
preoperative
|
16.7 scores on a scale
Standard Deviation 8.87
|
16.5 scores on a scale
Standard Deviation 7.6
|
|
Modified Fatigue Severity Scale
PACU
|
18.6 scores on a scale
Standard Deviation 11
|
26.9 scores on a scale
Standard Deviation 14.3
|
|
Modified Fatigue Severity Scale
Post op day 1
|
15.5 scores on a scale
Standard Deviation 9.9
|
25 scores on a scale
Standard Deviation 13.4
|
|
Modified Fatigue Severity Scale
Post op day #3
|
14.1 scores on a scale
Standard Deviation 6.57
|
20.8 scores on a scale
Standard Deviation 8.51
|
SECONDARY outcome
Timeframe: 2 hours post arrival in PACU.drawn in PACU 2 hours following arrival and compared to preoperative and intraoperative values
Outcome measures
| Measure |
Ibuprofen/Caldolor
n=24 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=25 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Immune Response:Serum Concentration of IL-10,
IL-10 PACU
|
8.3 pg/mL
Interval 0.1 to 32.2
|
21.8 pg/mL
Interval 0.1 to 113.0
|
|
Immune Response:Serum Concentration of IL-10,
IL-10 preoperatively
|
2.1 pg/mL
Interval 0.0 to 11.2
|
1.3 pg/mL
Interval 0.23 to 24.2
|
|
Immune Response:Serum Concentration of IL-10,
IL-10 intraoperatively
|
3.3 pg/mL
Interval 0.3 to 76.3
|
2.5 pg/mL
Interval 0.6 to 26.0
|
SECONDARY outcome
Timeframe: preoperatively- 2 hours in PACU, Post op day #1, post op day#3Digits span forward subject is asked to repeat a series of numbers with increasing number of digits forward. Digit span backward subject is asked to repeat a series of numbers backward with increasing number of digits. Correct response is worth 1 point. Maximum of 14 points for each sub score with a total of 28 points for total score
Outcome measures
| Measure |
Ibuprofen/Caldolor
n=28 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=27 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Cognitive Recovery.
preop forward total
|
8.4 units on a scale
Standard Deviation 1.9
|
8.9 units on a scale
Standard Deviation 1.6
|
|
Cognitive Recovery.
preoperative forward max len
|
6.9 units on a scale
Standard Deviation 0.89
|
7.08 units on a scale
Standard Deviation 0.8
|
|
Cognitive Recovery.
Pre op backward tot
|
7.7 units on a scale
Standard Deviation 2.08
|
7.7 units on a scale
Standard Deviation 1.9
|
|
Cognitive Recovery.
Preop backward max len
|
5.5 units on a scale
Standard Deviation 1.1
|
5.5 units on a scale
Standard Deviation 1.1
|
|
Cognitive Recovery.
PACU forward tot
|
4.7 units on a scale
Standard Deviation 2.6
|
4.4 units on a scale
Standard Deviation 2.5
|
|
Cognitive Recovery.
PACU for max length
|
4.8 units on a scale
Standard Deviation 1.7
|
4.4 units on a scale
Standard Deviation 1.8
|
|
Cognitive Recovery.
PACU backward tot
|
4.9 units on a scale
Standard Deviation 2.9
|
3.1 units on a scale
Standard Deviation 2.1
|
|
Cognitive Recovery.
PACU back max length
|
3.8 units on a scale
Standard Deviation 1.7
|
3.0 units on a scale
Standard Deviation 1.7
|
|
Cognitive Recovery.
Post op #1forward tot
|
8.7 units on a scale
Standard Deviation 1.6
|
8.8 units on a scale
Standard Deviation 1.6
|
|
Cognitive Recovery.
Post op day 1max length
|
7.03 units on a scale
Standard Deviation 0.89
|
7.6 units on a scale
Standard Deviation 0.89
|
|
Cognitive Recovery.
Post op #1backward tot
|
8.2 units on a scale
Standard Deviation 1.6
|
7.8 units on a scale
Standard Deviation 1.9
|
|
Cognitive Recovery.
Post op day #1max length
|
5.6 units on a scale
Standard Deviation 0.8
|
5.5 units on a scale
Standard Deviation 1.2
|
|
Cognitive Recovery.
Post op #3 forward tot
|
8.7 units on a scale
Standard Deviation 1.5
|
8.6 units on a scale
Standard Deviation 1.3
|
|
Cognitive Recovery.
post #3 for max length
|
6.9 units on a scale
Standard Deviation 0.89
|
6.8 units on a scale
Standard Deviation 0.6
|
|
Cognitive Recovery.
post op day #3backward tot
|
8.6 units on a scale
Standard Deviation 1.8
|
7.6 units on a scale
Standard Deviation 1.89
|
|
Cognitive Recovery.
post op #3 max length
|
6.03 units on a scale
Standard Deviation 1.09
|
5.5 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Preoperatively, post operative day 1 and post op day315 questions. Score 1 point for each answer selected which indicates depression. Score of 0-5 is normal. A score \>5 suggests depression.
Outcome measures
| Measure |
Ibuprofen/Caldolor
n=28 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=27 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Geriatric Depression Scale
preoperative score
|
0.5 units on a scale
Standard Deviation 1.1
|
0.7 units on a scale
Standard Deviation 1.4
|
|
Geriatric Depression Scale
PACU
|
0.7 units on a scale
Standard Deviation 0.9
|
0.9 units on a scale
Standard Deviation 0.7
|
|
Geriatric Depression Scale
post op day #1
|
0.4 units on a scale
Standard Deviation 1.1
|
0.4 units on a scale
Standard Deviation 0.8
|
|
Geriatric Depression Scale
post op day #3
|
0.2 units on a scale
Standard Deviation 0.8
|
0.12 units on a scale
Standard Deviation 0.3
|
POST_HOC outcome
Timeframe: intraoperativelyOutcome measures
| Measure |
Ibuprofen/Caldolor
n=24 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=25 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Sympathetic Response: Epinephrine and Norepinephrine Plasma Concentrations
Epinephrine Intraoperatively
|
0.11 pg/mL
Standard Deviation 0.03
|
0.23 pg/mL
Standard Deviation 0.05
|
|
Sympathetic Response: Epinephrine and Norepinephrine Plasma Concentrations
Norepinephrine Intraoperatively
|
0.52 pg/mL
Standard Deviation 0.09
|
1.06 pg/mL
Standard Deviation 0.12
|
POST_HOC outcome
Timeframe: preoperatively-intraoperatively-postoperativelyOutcome measures
| Measure |
Ibuprofen/Caldolor
n=24 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=25 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
Immune Response: TNF Alpha
TNF a post op
|
11.8 pg/mL
Interval 3.6 to 43.1
|
10.6 pg/mL
Interval 3.6 to 23.0
|
|
Immune Response: TNF Alpha
TNF a Preop
|
12.1 pg/mL
Interval 2.9 to 31.2
|
11.3 pg/mL
Interval 2.9 to 28.1
|
|
Immune Response: TNF Alpha
TNFa Intraop
|
14 pg/mL
Interval 4.5 to 76.7
|
8.9 pg/mL
Interval 2.8 to 21.0
|
POST_HOC outcome
Timeframe: preoperatively-intraoperatively-postoperativelyOutcome measures
| Measure |
Ibuprofen/Caldolor
n=24 Participants
800mg administered IV in 100cc of normal saline over 5 minutes
ibuprofen: single preoperative dose prior to surgery
|
Placebo
n=25 Participants
100mL of normal saline to be administered over 5 minutes
sugar water/placebo: single preoperative dose prior to surgery
|
|---|---|---|
|
IL-6
IL-6 preoperatively
|
1.4 pg/mL
Interval 0.3 to 22.2
|
1.2 pg/mL
Interval 0.4 to 14.5
|
|
IL-6
IL-6 intraoperatively
|
1.9 pg/mL
Interval 0.4 to 56.4
|
1.1 pg/mL
Interval 0.3 to 22.7
|
|
IL-6
IL-6 postoperatively
|
8.3 pg/mL
Interval 0.9 to 80.4
|
7.7 pg/mL
Interval 0.5 to 59.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: preoperative-intraoperative-postopoperativeIFN y, IL-1B IL-2 were below the limit of detection and no assessments could be made. The lower limit for all cytokine detection was 3.2pg/mL
Outcome measures
Outcome data not reported
Adverse Events
Caldolor/Ibuprofen
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caldolor/Ibuprofen
n=28 participants at risk
800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
|
Placebo
n=27 participants at risk
100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
|
|---|---|---|
|
Surgical and medical procedures
patient unable to be extubated at the end of the surgical procedure
|
3.6%
1/28 • -day of surgery to post operative day 3
|
0.00%
0/27 • -day of surgery to post operative day 3
|
Other adverse events
Adverse event data not reported
Additional Information
Alex Bekker, MD, PhD
Rutgers/State University of New Jersey (NJMS)
Phone: 973 972-5007
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place