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Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion

Oral Caffeine Decreases the Frequency of Opioid Demand in AIS Patients After Spinal Fusion

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04950660
Enrollment
61
Registered
2021-07-06
Start date
2019-12-11
Completion date
2024-08-01
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Brief summary

Prospective, randomized control trial To determine if oral caffeine decreases the frequency of opioid demand in children with adolescent idiopathic scoliosis after their spinal fusion surgery To compare pain scale ratings, number of requests for diazepam, average heart rate, average blood pressure, sex, age, ethnicity, post-op day of discharge, operative time, estimated intraoperative blood loss, remittance post-surgery, length of hospital stay, and segments fused during spinal fusion surgery.

Detailed description

Because these receptors are so important for modifying pain and inflammation, caffeine has been added as an adjuvant to common analgesics, such as paracetamol, ibuprofen, and aspirin in the belief that it will enhance their analgesic efficacy. Most studies used paracetamol or ibuprofen with 100 mg to 130 mg caffeine, and the most common pain conditions studied were postoperative dental pain, postpartum pain, and headache. There was a small but statistically significant benefit with caffeine used at doses of 100 mg or more, which was not dependent on the pain condition or type of analgesic. Additionally, trials have shown superior efficacy of adding caffeine to ibuprofen instead of administering ibuprofen alone for treating acute pain, reflecting that caffeine is an effective analgesic adjuvant. The addition of caffeine (≥ 100 mg) to a standard dose of commonly used analgesics provides a small but important increase in the proportion of participants who experience a good level of pain relief. Finally, the beneficial effects of caffeine on aerobic activity and resistance training performance are well documented. Studies have shown that caffeine ingestion resulted in significantly lower levels of soreness compared with placebo (p ≤ 0.05). A further beneficial effect of sustained caffeine ingestion in the days after the exercise bout is an attenuation of delayed onset muscle soreness. Orthopaedic surgery also causes muscle injury, and patients might benefit from caffeine's effect on lowering muscle soreness. Acute caffeine administration also has been shown to demonstrate increases in alertness, contentment, motivation to work, talkativeness, and energy. It also decreases muscle twitches. All of these effects would be beneficial in the post-operative period, especially for Adolescence Idiopathic Scoliosis (AIS) patients undergoing spinal fusion surgery in the orthopaedic department at Children's Mercy Hospital.

Interventions

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.

DRUGPlacebo

Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.

Sponsors

Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

This study will be a prospective, randomized control trial and will be double-blinded, with the patient, provider, and researcher blinded to the treatment.

Intervention model description

This study will be a prospective, randomized control trial and will be double-blinded, with the patient, provider, and researcher blinded to the treatment.

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* must meet criteria for surgical correction of scoliosis * must be able to swallow pills * must have English as a primary language * must possess mental capacity to understand purpose of the study * patient must carry diagnosis of adolescent idiopathic scoliosis * surgery must be performed via posterior approach * operation performed by either Dr. John T. Anderson, Dr. Richard M. Schwend, Dr. Aaron Shaw, Dr. Michael Benvenuti * post-surgical AIS patients from June 2019-June 2024 * the patient must be between the ages of 12 and 17 years old * the patient and one of their biological parents or guardian(s) must give consent for patient to be included in this study * Negative Suicide screen

Exclusion criteria

* obesity, as defined by a BMI at or above the 95th percentile * weight below 40 kg * any orthopedic diagnosis other than AIS * revision spine surgery * anterior or combined approach * admission to PICU post-op * use of Oxycodone post-op * allergies to ibuprofen, caffeine, codeine, or diazepam * history of renal disease * history of a coagulation disorder * history of cardiac dysrhythmia or open heart surgery * history of Chronic Pain Syndrome or Complex Regional Pain Syndrome * current use of oral central nervous system stimulant (e.g. methylphenidate) * Positive Suicide screen The following populations will be excluded: * Children over the age of 18, or turning 18 during time of surgical treatment * Children or parents unable to consent * Individuals with cognitive delays * Pregnant females * Prisoners * Wards of the state

Design outcomes

Primary

MeasureTime frameDescription
Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital StayFor hospital stay up to 7 daysTotal Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay

Secondary

MeasureTime frameDescription
Mean Daily Verbal Analog Scale (VAS)For hospital stay up to 7 daysUtilizing Verbal Analog Scale 0-10, 0 being no pain and 10 being severe pain
Average Heart Rate During Hospital StayFor hospital stay up to 7 daysDocumented heart rates which are then averaged over 24 hours
Average Systolic Blood Pressure During Hospital StayFor hospital stay up to 7 daysDocumented systolic blood pressures which are then averaged over 24 hours

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
24
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.
27
Total51

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyHypotension10
Overall StudyPoor pain control, switch to Oxycodone11
Overall StudyProtocol Violation42
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicCaffeine ArmPlacebo ArmTotal
Age, Categorical
<=18 years
24 Participants27 Participants51 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous14.25 years
STANDARD_DEVIATION 1.5
14.81 years
STANDARD_DEVIATION 1.4
14.55 years
STANDARD_DEVIATION 1.43
Complications0 Participants0 Participants0 Participants
Number of Segments Fused9.92 Number of segments
STANDARD_DEVIATION 2.1
10.52 Number of segments
STANDARD_DEVIATION 1.9
10.24 Number of segments
STANDARD_DEVIATION 1.98
Operative Time230.92 Minutes
STANDARD_DEVIATION 49.6
246.15 Minutes
STANDARD_DEVIATION 43.4
238.98 Minutes
STANDARD_DEVIATION 46.58
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants4 Participants8 Participants
Race (NIH/OMB)
White
20 Participants21 Participants41 Participants
Region of Enrollment
United States
24 participants27 participants51 participants
Sex: Female, Male
Female
22 Participants24 Participants46 Participants
Sex: Female, Male
Male
2 Participants3 Participants5 Participants
Weight53.8 Kg
STANDARD_DEVIATION 8.2
54.72 Kg
STANDARD_DEVIATION 7.1
54.29 Kg
STANDARD_DEVIATION 7.56

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 27
other
Total, other adverse events
0 / 240 / 27
serious
Total, serious adverse events
0 / 240 / 27

Outcome results

Primary

Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay

Total Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay

Time frame: For hospital stay up to 7 days

ArmMeasureValue (MEAN)Dispersion
Caffeine ArmTotal Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay0.83 MME/KgStandard Deviation 0.41
Placebo ArmTotal Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay0.92 MME/KgStandard Deviation 0.33
Secondary

Average Heart Rate During Hospital Stay

Documented heart rates which are then averaged over 24 hours

Time frame: For hospital stay up to 7 days

ArmMeasureValue (MEAN)Dispersion
Caffeine ArmAverage Heart Rate During Hospital Stay78.8 Beats per minute/dayStandard Deviation 10.3
Placebo ArmAverage Heart Rate During Hospital Stay83.8 Beats per minute/dayStandard Deviation 12.4
Secondary

Average Systolic Blood Pressure During Hospital Stay

Documented systolic blood pressures which are then averaged over 24 hours

Time frame: For hospital stay up to 7 days

ArmMeasureValue (MEAN)Dispersion
Caffeine ArmAverage Systolic Blood Pressure During Hospital Stay98.3 mmHg/dayStandard Deviation 6.5
Placebo ArmAverage Systolic Blood Pressure During Hospital Stay101.4 mmHg/dayStandard Deviation 6.6
Secondary

Mean Daily Verbal Analog Scale (VAS)

Utilizing Verbal Analog Scale 0-10, 0 being no pain and 10 being severe pain

Time frame: For hospital stay up to 7 days

ArmMeasureValue (MEAN)Dispersion
Caffeine ArmMean Daily Verbal Analog Scale (VAS)3.33 Units on a scale/dayStandard Deviation 1.65
Placebo ArmMean Daily Verbal Analog Scale (VAS)3.51 Units on a scale/dayStandard Deviation 1.48

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026