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

Phase 4

Completed

Conditions: Adolescent Idiopathic Scoliosis

Interventions: Drug: Caffeine Tablet
Drug: Placebo

Registration Number: NCT04950660

Lead Sponsor: Children's Mercy Hospital Kansas City

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 61

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caffeine arm	Caffeine Tablet	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.
Placebo arm	Caffeine Tablet	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.
Placebo arm	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay	For hospital stay up to 7 days	Total Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay

Secondary Outcome Measures

Name	Time	Method
Mean Daily Verbal Analog Scale (VAS)	For hospital stay up to 7 days	Utilizing Verbal Analog Scale 0-10, 0 being no pain and 10 being severe pain
Average Heart Rate During Hospital Stay	For hospital stay up to 7 days	Documented heart rates which are then averaged over 24 hours
Average Systolic Blood Pressure During Hospital Stay	For hospital stay up to 7 days	Documented systolic blood pressures which are then averaged over 24 hours