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Stimulant

Caffeine Tablets for Post-Surgical Pain in Scoliosis

Phase 4

Recruiting

Led By Anne S Stuedemann, APN, MSN

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must possess mental capacity to understand purpose of the study

Operation performed by either Dr. John T. Anderson, Dr. Richard M. Schwend, Dr. Aaron Shaw, Dr. Michael Benvenuti

Must not have

History of renal disease

Allergies to ibuprofen, caffeine, codeine, or diazepam

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for hospital stay up to 7 days

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Approved for 10 Other Conditions

Summary

This trial is testing whether caffeine can help reduce the amount of pain medication needed after surgery for scoliosis.

Who is the study for?

This trial is for children aged 12-17 with adolescent idiopathic scoliosis undergoing spinal fusion surgery by specific doctors using a posterior approach. Participants must speak English, be able to swallow pills, and not have certain medical conditions like heart issues or obesity.

What is being tested?

The study tests if caffeine tablets can reduce opioid use after surgery compared to a placebo. It also looks at pain levels, medication requests, vital signs, demographic factors, surgical details like blood loss and segments fused, and hospital stay duration.

What are the potential side effects?

Potential side effects of caffeine may include nervousness, restlessness, insomnia, stomach irritation, nausea and vomiting; increased heart rate or respiration; headache; anxiety; chest pain; ringing in the ears.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the purpose of this study.

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My surgery was performed by Dr. Anderson, Dr. Schwend, Dr. Shaw, or Dr. Benvenuti.

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I am between 12 and 17 years old.

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I am eligible for surgery to correct my scoliosis.

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My surgery will be done through the back of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of kidney disease.

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I am allergic to ibuprofen, caffeine, codeine, or diazepam.

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I will be using Oxycodone after surgery.

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My bone condition is not adolescent idiopathic scoliosis.

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I am currently taking medication for my brain like methylphenidate.

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I have had heart rhythm problems or open heart surgery.

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I have a history of blood clotting issues.

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My weight is under 40 kg.

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I was admitted to the Pediatric Intensive Care Unit after surgery.

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I am scheduled for or have had a revision spine surgery.

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My BMI is in the top 5% for my age and height.

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I have a history of chronic pain or complex regional pain syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for hospital stay up to 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for hospital stay up to 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and for hospital stay up to 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Total number of demands for oral opioids from transition off PCA until discharge from hospital

Secondary study objectives

Average heart rate during hospital stay

Average systolic blood pressure during hospital stay

Verbal analog pain scale ratings

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Caffeine armActive Control1 Intervention

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.

Group II: Placebo armPlacebo Group2 Interventions

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.

0 / 17Eligibility criteria met