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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950660
• Other study ID #: STUDY00000775
• Status: Recruiting
• Phase: Phase 4
• Start date: December 11, 2019
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Anne S Stuedemann, APN, MSN
• Phone: 816-234-3693
• Email: astuedemann[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
United States	Children'S Mercy Hospitals & Clinic	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Average heart rate during hospital stay	Documented heart rates which are then averaged over 24 hours	For hospital stay up to 7 days
Secondary	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