Oral Caffeine Use for Pain Management 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.
Conditions:
🦠 Adolescent Idiopathic Scoliosis
🗓️ Study Start (Actual) 11 December 2019
🗓️ Primary Completion (Estimated) November 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 81
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Kansas City, Missouri, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 12 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 June 2021
  • First Submitted that Met QC Criteria 25 June 2021
  • First Posted 6 July 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 January 2024
  • Last Update Posted 23 January 2024
  • Last Verified January 2024