CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 61 enrolled
Drug / intervention
Caffeine Tablet +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04950660
NCT04950660Phase 4Completed

Oral Caffeine Decreases the Frequency of Opioid Demand in AIS Patients After Spinal Fusion

Children's Mercy Hospital Kansas City·interventional·Posted Jul 6, 2021·Updated Feb 21, 2025

In Brief

A Phase 4 clinical trial evaluating Caffeine Tablet and Placebo for Adolescent Idiopathic Scoliosis. Completed, enrolled 61 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJul 6, 2021
Enrollment StartDec 11, 2019
Primary CompletionJan 20, 2024
Study CompletionAug 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 5.0 years ago

Interventions

Caffeine Tabletdrug

Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet.

Placebodrug

Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.