This trial is being completed to compare two commonly used options to treat pain after discharge from surgery. Participants that undergo tonsil removal, gallbladder removal, and knee scope will be eligible to enroll. Eligible participants will be randomized to prescription of 1 of 2 groups of medications (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) plus acetaminophen or low dose opioids with the NSAIDs plus acetaminophen. The key question the study seeks to answer is which option will have the best outcomes and with the fewest side effects?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
900
Once randomized to this group the surgical team will elect to prescribe 1 of the following treatment options for post-discharge pain: * Ibuprofen 10 milligrams(mg)/kilogram (kg) (maximum 600mg) by mouth every 6 hours around the clock for 2 days, then as needed for pain thereafter (40 doses) * Celecoxib 6mg/kg (maximum 400mg) by mouth once then 3 mg/kg (maximum 200mg) every 12 hours around the clock for 2 days, then as needed for pain thereafter (40 doses)
Once randomized to this group the surgical team will elect to prescribe for 1 of the following treatment options to be given post procedure for post-discharge pain: * Oxycodone 0.1 mg/kg (maximum 5 mg) by mouth every 4 to 6 hours as needed for pain, number 10 doses. * Hydromorphone 0.04 mg/kg (maximum mg) by mouth 4 to 6 hours as needed, number 10 doses
Participants will receive 15mg/kg up to 1000mg by mouth every 6 hours around the clock for the first 2 days after discharge from surgery then as needed thereafter (40 doses)
Ibuprofen 10mg/kg (maximum 600 mg) by mouth every 6 hours around the clock for 2 days after discharge from surgery then as needed thereafter (40 doses)
Children's Hospital Los Angeles (CHLA)
Los Angeles, California, United States
RECRUITINGLucile Packard Children's Hospital Stanford
Palo Alto, California, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGNationwide Children's (NCH)
Columbus, Ohio, United States
RECRUITINGEffectiveness outcome - Pain intensity based on Brief Pain Inventory (BPI) pain intensity score at the surgical site over 14 days post-surgery
This is a one question survey in which the worst pain intensity recorded (0-10 being the worst) will be used.
Time frame: 14 days post-surgery, and up to 12 months after surgery
Safety outcome - number and severity of any adverse medication-related symptoms over 14 days post-surgery
Symptom Checklist will proactively screen patients for reports of adverse events from analgesic medications over the first 14 days post-surgery.
Time frame: 14 days post-surgery, and 1 month after surgery
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance v1.0 short form 4a
This is a 4-question survey in which participants will rate statements pertaining to quality of sleep. Participants will also rate sleep quality as very poor (5), poor (4), fair (3), good (2), or very good (1).
Time frame: Baseline and 1 month after surgery
Patient Global Impression of Change (PGIC)
The perception of improvement or worsening after treatment will be assessed by the patient global impression of change PGIC (range 0-7).
Time frame: Day 7 up to 12 months after surgery
PROMIS Pediatric Pain Interference scale (Short form-8a)
This is an 8-question survey in which participants will rate statements pertaining to how pain interferes with activities and function.
Time frame: Baseline up to 12 months after surgery
Pain Catastrophizing Scale (PCS)
This is a 6-question survey in which participants will rate statements pertaining to their experience of pain.
Time frame: Baseline up to 12 months after surgery
Pediatric Quality of Life Inventory Short Form 15
There are 15 questions with four scales for function related to physical, emotional, social, and school dimensions for adolescents. Participants answer questions from never (0) to almost always (4).
Time frame: Baseline up to 12 months after surgery
Quality of Recovery (QoR) 15
There are 15 questions assessed on a scale of 1-10, with 0 being none of the time and 10 being all of the time, 10 being the better outcome.
Time frame: Day 3, 1 week, and 2 weeks after surgery
Patient Health Questionnaire (PHQ-2)
There are 2 questions that are completed to screen for depression. Participants answer from not at all (0) to Nearly every day (3). The scores range from 0-6 with a higher score indicating higher levels of depression.
Time frame: Baseline up to 12 months after surgery
Generalized Anxiety Disorder (GAD-2)
There are 2 questions that are completed to screen for anxiety. Participants answer from not at all (0) to Nearly every day (3). The scores range from 0-6 with a higher score indicating higher levels of anxiety.
Time frame: Baseline up to 12 months after surgery
Brief Screening Instrument for Adolescent Tobacco, Alcohol, and Drug Use
This is a 6-question survey about the participants' use of tobacco, alcohol and drugs.
Time frame: Baseline up to 12 months after surgery
National Survey on Drug Use and Health Questions on Opioid Misuse
This is a one question survey that assesses opioid misuse defined as use that is more than prescribed, for non pain-related reasons, or in a way not prescribed by a doctor.
Time frame: Baseline up to 12 months after surgery
New prolonged opioid use
One question that will assess opioid prescription fills to identify new prolonged opioid use after surgery
Time frame: Up to 12 months after surgery
Acute pain based on The Michigan Body Map
Participants will document/mark on this image map to identify areas in which acute pain was felt.
Time frame: Up to 12 months after surgery
Chronic pain based on Body Map
Participants will document/mark on this image map to identify areas in which persistent or recurrent pain was felt.
Time frame: Up to 12 months after surgery
Chronic pain based on Brief Pain Inventory (BPI) pain intensity score up to 12 months after surgery
One question survey in which the participants rate pain intensity recorded (0-10), ten being the worst.
Time frame: to 12 months after surgery
Healthcare Utilization related to pain
Participants will answer questions about their healthcare utilization related to pain for the following three events: (1) postoperative clinical interactions related to pain in the form of patient messages, phone calls, and non-routine clinic visits related to pain, (2) emergency room visits, and (3) hospitalizations. The study team will also review health record for the same events.
Time frame: Up to 12 months after surgery
Analgesic medication use
Participants will answer questions about their analgesic medication use for acetaminophen, NSAIDs, opioids, and other medications, including prescription fills, over-the-counter use, and consumption. The study team will also review health record for prescription fills.
Time frame: Up to 12 months after surgery
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