Adolescent Idiopathic ScoliosisPhase 4NCT04950660
Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion
A Phase 4 study testing Caffeine Tablet in people with Adolescent Idiopathic Scoliosis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Caffeine Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2019to 1 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children'S Mercy Hospitals & Clinic
Kansas City, Missouri, 64114
About this study
Official title: Oral Caffeine Decreases the Frequency of Opioid Demand in AIS Patients After Spinal Fusion
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Caffeine Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine TabletDrug
Also called Caffeine
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.
PlaceboDrug
Also called Blank
Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine arm | Active comparator | 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. Receives: Drug: Caffeine Tablet |
| Placebo arm | Placebo comparator | 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. Receives: Drug: Caffeine Tablet; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: For hospital stay up to 7 days
Secondary outcomes (3)
Mean Daily Verbal Analog Scale (VAS)
Utilizing Verbal Analog Scale 0-10, 0 being no pain and 10 being severe pain
Measured: For hospital stay up to 7 days
Average Heart Rate During Hospital Stay
Documented heart rates which are then averaged over 24 hours
Measured: For hospital stay up to 7 days
Average Systolic Blood Pressure During Hospital Stay
Documented systolic blood pressures which are then averaged over 24 hours
Measured: For hospital stay up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start11 Dec 2019
- Primary completion20 Jan 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Stuedemann, Children's Mercy Hospital Kansas City
- Investigators
- Anne S Stuedemann, APN, MSN, Principal investigator, CHILDREN'S MERCY HOSPITALS & CLINICS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950660
- Sponsor's protocol ID
- STUDY00000775
- Status last verified
- Jan 2025
- First submitted
- 15 Jun 2021
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: only the research team will have access to study results. No IPD will be shared with anyone outside of the research team.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Caffeine Decreases the Frequency of Opioid Demand in AIS Patients After Spinal Fusion
- ClinicalTrials.gov ID
- NCT04950660
- Acronym / sponsor ID
- STUDY00000775
- Conditions
- Adolescent Idiopathic Scoliosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caffeine arm | Active comparator | Drug: Caffeine TabletExperimental 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. |
| Placebo arm | Placebo comparator | Drug: Caffeine Tablet, Drug: PlaceboControl 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine TabletAlso: CaffeineCaffeine 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. | Drug | Caffeine arm, Placebo arm |
| PlaceboAlso: BlankPlacebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control. | Drug | Placebo arm |
Primary outcome
Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay
Time frame: For hospital stay up to 7 days
Total Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay
3 secondary outcomes
Mean Daily Verbal Analog Scale (VAS)
Time frame: For hospital stay up to 7 days
Average Heart Rate During Hospital Stay
Time frame: For hospital stay up to 7 days
Average Systolic Blood Pressure During Hospital Stay
Time frame: For hospital stay up to 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. only the research team will have access to study results. No IPD will be shared with anyone outside of the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne S Stuedemann, APN, MSN principal investigator
CHILDREN'S MERCY HOSPITALS & CLINICS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caffeine Tablet in people with Adolescent Idiopathic Scoliosis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay (time frame: For hospital stay up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.