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

NCT04950660 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00000775
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay

  Total Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay

  For hospital stay up to 7 days

Secondary Outcomes (3)

• Mean Daily Verbal Analog Scale (VAS)

  For hospital stay up to 7 days

• Average Heart Rate During Hospital Stay

  For hospital stay up to 7 days

• Average Systolic Blood Pressure During Hospital Stay

  For hospital stay up to 7 days

Study Arms (2)

Caffeine arm

ACTIVE COMPARATOR

Experimental Group: patient group (n = 34) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.

Drug: Caffeine Tablet

Placebo arm

PLACEBO COMPARATOR

Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.

Drug: Caffeine Tablet; Drug: Placebo

Interventions

Caffeine Tablet DRUG

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.

Also known as: Caffeine

Caffeine arm; Placebo arm

Placebo DRUG

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

Also known as: Blank

Placebo arm

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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:

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children'S Mercy Hospitals & Clinic

Kansas City, Missouri, 64114, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Anne Stuedemann MSN, RN, CPNP
• Organization: Children's Mercy Kansas City

astuedemann@cmh.edu

8162343693

Study Officials

• Anne S Stuedemann, APN, MSN

  CHILDREN'S MERCY HOSPITALS & CLINICS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study will be a prospective, randomized control trial and will be double-blinded, with the patient, provider, and researcher blinded to the treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: APRN III

Model Details: This study will be a prospective, randomized control trial and will be double-blinded, with the patient, provider, and researcher blinded to the treatment.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 6, 2021
• Study Start: December 11, 2019
• Primary Completion: January 20, 2024
• Study Completion: August 1, 2024
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)