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

Completed · Phase 4 · Has a placebo group

Conditions studied: Adolescent Idiopathic Scoliosis

In brief

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.

Key facts

Study ID

NCT04950660

Run by

Children's Mercy Hospital Kansas City

People needed

61

Starts

2019-12-11

Expected to finish

2024-08-01

Last updated by the study team

2025-02-21

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children'S Mercy Hospitals & Clinic — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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