Phase 4 N=61 Randomized Triple-blind Supportive Care

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

Adolescent Idiopathic Scoliosis

Bottom Line

View on ClinicalTrials.gov: NCT04950660 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay — 0.83; 0.92 MME/Kg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Caffeine Tablet (Drug); Placebo (Drug)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: Children's Mercy Hospital Kansas City
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay	0.83; 0.92	—
SECONDARY Mean Daily Verbal Analog Scale (VAS)	3.33; 3.51	—
SECONDARY Average Heart Rate During Hospital Stay	78.8; 83.8	—
SECONDARY Average Systolic Blood Pressure During Hospital Stay	98.3; 101.4	—

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, 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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04950660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.