An Early Phase 1 interventional study of Dexamethasone injection and Saline injection in Spinal Fusion, sponsored by University of Texas at Austin. Enrolling by invitation at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by University of Texas at Austin · Early Phase 1, Interventional, and Treatment
Current efforts to improve pain alleviation focus on non-opioid pharmaceuticals. Intravenous perioperative corticosteroid administration has been suggested as an alternative method for post-operative pain control. The evidence regarding perioperative intravenous corticosteroids to help alleviate post-operative pain is mixed. Some meta-analyses report decreased opioid consumption and decreased pain intensity after a variety of surgical procedures. However, a study of larger orthopedic procedures found no benefit. The catabolic and immunosuppressant effects of corticosteroids also pose issues with wound healing and infection, which can have severe consequences after spine surgery. There is limited data on the effect of perioperative intravenous steroid administration on pain alleviation in children having surgery to address spine deformity. A recent retrospective review demonstrated that perioperative corticosteroid administration was associated with a statistically significant decrease in opioid medication utilization among children and adolescents after spinal deformity surgery. While not increasing the risk of postoperative complications. The investigators hypothesize that the administration of perioperative intravenous dexamethasone will demonstrate a clinically meaningful and statistically significant decrease in postoperative pain intensity, need for opioid medications, time to ambulation, and length of stay in children recovering from surgery for spine deformity.
University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Exclusion Criteria:
Dexamethasone will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs
Drug: Dexamethasone injection
Saline will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs
Other: Saline injection
Dexamethasone will be injected at the dosage recommended by the FDA.
Saline will be injected for the placebo arm of the study.
Time to initial ambulation post-operatively and distance ambulated in first physical therapy session.
The investigators will assess the time to initial ambulation in reference to the surgical stop time recorded in the chart. This time will be calculated in minutes. The total minutes until first ambulation for both arms of the study will be compared. The investigators will assess measure, in feet, the distance patients ambulate during the initial session with physical therapy postoperatively. The distance, in feet, ambulated by patient in each arm of the study will be directly compared.
Time frame: 1 week
Length of stay in hospital
The investigators will measure the number of days in the hospital from the date of surgery
Time frame: 1 week
Morphine equivalents use
The investigators will record the amount of morphine equivalents utilized by patients in the post-operative in-hospital period to compare the use of intravenous narcotics in a quantifiable fashion between the two study groups.
Time frame: 1 week
Return to emergency department
The investigators will track rates of return to the Emergency Department and/or return for hospital admission after discharge from the hospital. Rates of return to the Emergency Department and/or need for hospital admission will be stratified across 30 day, 90 day, and 365 day intervals after discharge from the hospital. Additionally, data will be collected by the investigators on the cause of return to the Emergency Department and/or return for hospital admission. Examples of cause for return will include: insufficient pain control at home, concerning neurologic findings, inability to tolerate per os nutrition, inability to urinate or defecate, wound dehiscence or drainage, and all other causes. We will keep track of patients that need to return to the emergency department for any reason.
Time frame: 12 months
Return to school
The investigators will determine the length of time it takes a patient to return to school after surgery.
Time frame: 3 months
Pain score at discharge
The investigators will record the patient's pain score at regular intervals during hospital admission (typically assessed every 4 hours by the nursing staff) as well as recording pain score at time of discharge from the hospital. Pain scores will be recorded in two fashions. Primarily, a pain score of 0 to 10 will be recorded whereby a patient-reported score of "0" indicates no perceived pain and a score of "10" would indicate severe and intractable pain. Secondarily, as this study involves pediatric patients, the investigators will record pain using the Wong-Baker FACES Pain Rating Scale that similarly uses a scoring system of 0 to 10, but additionally includes illustrations of faces to guide pediatric patients in relating their pain to a numeric score. The Wong-Baker FACES Pain Rating Scale is a validated tool for recording pain levels in pediatric patients and is widely used within the investigators hospital system.
Time frame: 1 week
Plan to share: No — We plan to publish the results of this study. All protected health information (PHI) will be delinked from the participant and will only be accessed by authorized research personnel. IPD will be destroyed at the end of the study.
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University of Texas at Austin