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

  • STATUS
    Recruiting
  • End date
    Nov 15, 2024
  • participants needed
    68
  • sponsor
    Children's Mercy Hospital Kansas City
Updated on 15 July 2021

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.

Details
Condition Adolescent Idiopathic Scoliosis
Treatment Placebo, Caffeine tablet
Clinical Study IdentifierNCT04950660
SponsorChildren's Mercy Hospital Kansas City
Last Modified on15 July 2021

Eligibility

Yes No Not Sure

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 or Dr. Richard M. Schwend
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

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)
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