Trial Outcomes & Findings for Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion (NCT NCT04950660)
NCT ID: NCT04950660
Last Updated: 2025-02-21
Results Overview
Total Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
61 participants
Primary outcome timeframe
For hospital stay up to 7 days
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
Caffeine Arm
Experimental Group: patient group (n = 34) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
|
Placebo Arm
Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
Placebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
24
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Caffeine Arm
Experimental Group: patient group (n = 34) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
|
Placebo Arm
Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
Placebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
Poor pain control, switch to Oxycodone
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Hypotension
|
1
|
0
|
Baseline Characteristics
Did not measure combined weight
Baseline characteristics by cohort
| Measure |
Caffeine Arm
n=24 Participants
Experimental Group: patient group (n = 34) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
|
Placebo Arm
n=27 Participants
Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
Placebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
14.25 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
14.81 years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
14.55 years
STANDARD_DEVIATION 1.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Weight
|
53.8 Kg
STANDARD_DEVIATION 8.2 • n=5 Participants • Did not measure combined weight
|
54.72 Kg
STANDARD_DEVIATION 7.1 • n=7 Participants • Did not measure combined weight
|
54.29 Kg
STANDARD_DEVIATION 7.56 • n=5 Participants • Did not measure combined weight
|
|
Complications
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Operative Time
|
230.92 Minutes
STANDARD_DEVIATION 49.6 • n=5 Participants
|
246.15 Minutes
STANDARD_DEVIATION 43.4 • n=7 Participants
|
238.98 Minutes
STANDARD_DEVIATION 46.58 • n=5 Participants
|
|
Number of Segments Fused
|
9.92 Number of segments
STANDARD_DEVIATION 2.1 • n=5 Participants
|
10.52 Number of segments
STANDARD_DEVIATION 1.9 • n=7 Participants
|
10.24 Number of segments
STANDARD_DEVIATION 1.98 • n=5 Participants
|
PRIMARY outcome
Timeframe: For hospital stay up to 7 daysTotal Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay
Outcome measures
| Measure |
Caffeine Arm
n=24 Participants
Experimental Group: patient group (n = 24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
|
Placebo Arm
n=27 Participants
Control group: patient group (n = 27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
Placebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
|
|---|---|---|
|
Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay
|
0.83 MME/Kg
Standard Deviation 0.41
|
0.92 MME/Kg
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: For hospital stay up to 7 daysUtilizing Verbal Analog Scale 0-10, 0 being no pain and 10 being severe pain
Outcome measures
| Measure |
Caffeine Arm
n=24 Participants
Experimental Group: patient group (n = 24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
|
Placebo Arm
n=27 Participants
Control group: patient group (n = 27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
Placebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
|
|---|---|---|
|
Mean Daily Verbal Analog Scale (VAS)
|
3.33 Units on a scale/day
Standard Deviation 1.65
|
3.51 Units on a scale/day
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: For hospital stay up to 7 daysDocumented heart rates which are then averaged over 24 hours
Outcome measures
| Measure |
Caffeine Arm
n=24 Participants
Experimental Group: patient group (n = 24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
|
Placebo Arm
n=27 Participants
Control group: patient group (n = 27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
Placebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
|
|---|---|---|
|
Average Heart Rate During Hospital Stay
|
78.8 Beats per minute/day
Standard Deviation 10.3
|
83.8 Beats per minute/day
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: For hospital stay up to 7 daysDocumented systolic blood pressures which are then averaged over 24 hours
Outcome measures
| Measure |
Caffeine Arm
n=24 Participants
Experimental Group: patient group (n = 24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
|
Placebo Arm
n=27 Participants
Control group: patient group (n = 27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.
Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.
Placebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
|
|---|---|---|
|
Average Systolic Blood Pressure During Hospital Stay
|
98.3 mmHg/day
Standard Deviation 6.5
|
101.4 mmHg/day
Standard Deviation 6.6
|
Adverse Events
Caffeine Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anne Stuedemann MSN, RN, CPNP
Children's Mercy Kansas City
Phone: 8162343693
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place