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

NCT ID: NCT04950660

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-11
• Study Completion Date: 2024-08-01

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Caffeine Tablet

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Caffeine Tablet

Intervention Type: 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.

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Caffeine; Blank

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Anne Stuedemann

APRN III

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne S Stuedemann, APN, MSN

Role: PRINCIPAL_INVESTIGATOR

CHILDREN'S MERCY HOSPITALS & CLINICS

Locations

Children'S Mercy Hospitals & Clinic

Kansas City, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00000775

Identifier Type: -

Identifier Source: org_study_id