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

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

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 Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Drug: Caffeine Tablet; Drug: Placebo

Detailed Description

Because these receptors are so important for modifying pain and inflammation, caffeine has been added as an adjuvant to common analgesics, such as paracetamol, ibuprofen, and aspirin in the belief that it will enhance their analgesic efficacy. Most studies used paracetamol or ibuprofen with 100 mg to 130 mg caffeine, and the most common pain conditions studied were postoperative dental pain, postpartum pain, and headache. There was a small but statistically significant benefit with caffeine used at doses of 100 mg or more, which was not dependent on the pain condition or type of analgesic. Additionally, trials have shown superior efficacy of adding caffeine to ibuprofen instead of administering ibuprofen alone for treating acute pain, reflecting that caffeine is an effective analgesic adjuvant. The addition of caffeine (≥ 100 mg) to a standard dose of commonly used analgesics provides a small but important increase in the proportion of participants who experience a good level of pain relief.

Finally, the beneficial effects of caffeine on aerobic activity and resistance training performance are well documented. Studies have shown that caffeine ingestion resulted in significantly lower levels of soreness compared with placebo (p ≤ 0.05). A further beneficial effect of sustained caffeine ingestion in the days after the exercise bout is an attenuation of delayed onset muscle soreness. Orthopaedic surgery also causes muscle injury, and patients might benefit from caffeine's effect on lowering muscle soreness. Acute caffeine administration also has been shown to demonstrate increases in alertness, contentment, motivation to work, talkativeness, and energy. It also decreases muscle twitches. All of these effects would be beneficial in the post-operative period, especially for Adolescence Idiopathic Scoliosis (AIS) patients undergoing spinal fusion surgery in the orthopaedic department at Children's Mercy Hospital.

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anne S Stuedemann, APN, MSN; Phone Number: 816-234-3693; Email: astuedemann@cmh.edu
• Study Contact Backup: Name: JULIA LEAMON, MSN, RN; Phone Number: 816-460-1036; Email: jleamon@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Recruiting
      • Children'S Mercy Hospitals & Clinic
      • Contact: JULIA LEAMON, MSN, RN; Phone Number: 816-460-1036; Email: jleamon@cmh.edu
      • Contact: ANNE STUEDEMANN, APN, MSN; Phone Number: 816-234-3693; Email: astuedemann@cmh.edu
      • Sub-Investigator: RICHARD M SCHWEND, MD
      • Sub-Investigator: JOHN T ANDERSON, MD
      • Sub-Investigator: NICOLETTE SADDLER, MSN
      • Sub-Investigator: MICHON HUSTON, PA-C
      • Sub-Investigator: ARMAND MOREL, MD
      • Sub-Investigator: ASHLEY SHERMAN, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Caffeine arm; 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; 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.; Other Names: Caffeine
Placebo Comparator: Placebo arm; 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; 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.; Other Names: Caffeine; Drug: Placebo; Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control.; Other Names: Blank

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of demands for oral opioids from transition off PCA until discharge from hospital	Documented opioid use	For hospital stay up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal analog pain scale ratings	Utilizing Verbal Analog Scale 0-10, 0 being no pain and 10 being severe pain	For hospital stay up to 7 days
Average heart rate during hospital stay	Documented heart rates which are then averaged over 24 hours	For hospital stay up to 7 days
Average systolic blood pressure during hospital stay	Documented systolic blood pressures which are then averaged over 24 hours	For hospital stay up to 7 days

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Anne S Stuedemann, APN, MSN, CHILDREN'S MERCY HOSPITALS & CLINICS

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: STUDY00000775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only the research team will have access to study results. No IPD will be shared with anyone outside of the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No