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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for hospital stay up to 7 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Average heart rate during hospital stay

Average systolic blood pressure during hospital stay

Verbal analog pain scale ratings

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,718 Total Patients Enrolled

Anne S Stuedemann, APN, MSNPrincipal InvestigatorCHILDREN'S MERCY HOSPITALS & CLINICS

Media Library

Caffeine Tablet (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT04950660 — Phase 4

Adolescent Idiopathic Scoliosis Research Study Groups: Caffeine arm, Placebo arm

Adolescent Idiopathic Scoliosis Clinical Trial 2023: Caffeine Tablet Highlights & Side Effects. Trial Name: NCT04950660 — Phase 4

Caffeine Tablet (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04950660 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What precedent has been set for the use of Caffeine in clinical experimentation?

"Presently, 13 clinical trials researching Caffeine arm are running with 2 in Phase 3. Majority of the studies take place in Chongqing while other sites span 121 locations across the globe."

Answered by AI

What are the potential hazards associated with consuming caffeine for medical purposes?

"Since caffeine is an approved treatment, we have rated its safety as a 3 on our scale. This indicates that the Phase 4 trial has yielded numerous data points demonstrating its efficacy and reliability."

Answered by AI

What criteria must a person fulfill in order to participate in this research?

"To be eligible for this clinical trial, candidates should have scoliosis and fall within the juvenile age range of 12 to 17. The research team is aiming to recruit a total of 68 participants."

Answered by AI

Are seniors within the age range of 55+ being enrolled in this experiment?

"As indicated by the requirements for inclusion, the age range of participants should be between 12 and 17 years old."

Answered by AI

What have studies suggested is the therapeutic potential of Caffeine arm?

"Caffeine arm is a common remedy for respiratory depression and can also alleviate pain associated with menses, myalgia, and other afflictions."

Answered by AI

Is recruitment for the experiment still active?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical research project is currently trying to find eligible participants and was officially announced on December 11th 2019. As of September 6th 2022, 68 patients are needed from a single site for enrollment in the study."

Answered by AI

What is the ceiling of patient enrollment for this experiment?

"Affirmative, the clinicaltrials.gov records hint that this trial is presently in search of volunteers. It was initially posted on December 11th 2019 and its most recent revision occurred September 6th 2022. 68 participants have to be recruited at 1 medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Anne Stuedemann 2019. "Oral Caffeine Use for Pain Management in AIS Patients After Spinal Fusion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04950660.

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