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

NCT04950660 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-02-21

Study results available
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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.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

DRUG

Caffeine Tablet

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • Anne S Stuedemann, APN, MSN · CHILDREN'S MERCY HOSPITALS & CLINICS

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2024-01-20
Completion
2024-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04950660 on ClinicalTrials.gov