Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether perioperative intravenous acetaminophen administration reduces postoperative pain and opioid consumption in adolescents and pediatric patients undergoing spinal fusion surgery.

Detailed Description
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Spinal fusion surgery to correct scoliosis causes severe postoperative pain in adolescents and pediatric patients. Thus, appropriate control of postoperative pain has a significant impact on postoperative recovery, patient satisfaction and reduction of hospital stay. Although pain control was achieved through only opioids, the importance of multimodal analgesia has recently been emphasized as opioid addiction and side effects increase. Acetaminophen is recommended as a key factor in multimodal analgesia and previous studies performed in adult spine surgery showed that intravenous administration of acetaminophen reduced the postoperative pain and opioid consumption. In addition, acetaminophen is a drug widely recognized for safety in adolescents and pediatric patients and has a fast and predictable analgesic effect. Therefore, the purpose of this study is to investigate whether perioperative intravenous acetaminophen administration reduces postoperative pain and opioid consumption in adolescents and pediatric patients undergoing spinal fusion surgery. Thus the specific aim of this trial the investigators will determine is; The decrease in postoperative analgesic requirement following IV acetaminophen The decrease in intensity of postoperative pain following IV acetaminophen The quality of recovery including self-reported recovery, physical and functional recovery and length of stay The preemptive analgesic effect of IV acetaminophen

Official Title
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Use of Intravenous Acetaminophen in Adolescents and Pediatrics Undergoing Spinal Fusion Surgery: Randomized Controlled Trial

Conditions
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Scoliosis; Adolescence

Intervention / Treatment
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* Drug: intravenous acetaminophen
* Drug: intravenous acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1-3 patients undergoing spinal fusion surgery Exclusion Criteria: patients who refuse to participate in this study patients unable to communicate due to mental impairment or developmental delay patients allergic to acetaminophen or its additives or who are contraindicated in acetaminophen administration for other reasons patients with existing liver diseases or dysfunction (i.e. active hepatitis, clinically relevant chronic liver conditions, elevated liver enzymes) patients who are judged ineligible by the medical staff to participate in the study for other reasons

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental (Pre): Acetaminophen<br>Participants will receive 15mg/kg intravenous acetaminophen 15mg/kg after anesthetic induction/before surgical incision and the same dose will be given postoperatively at 8 hour intervals for 24hours. A single dose of placebo (saline) will also be given at the end of surgery before skin closure. | Drug: intravenous acetaminophen<br>* experimental(pre): administration of IV acetaminophen<br>|
| Experimental: Experimental(post): Acetaminophen<br>Participants will receive 15mg/kg intravenous acetaminophen 15mg/kg at the end of surgery before skin closure and the same dose will be given postoperatively at 8 hour intervals for 24hours. A single dose of placebo (saline) will also be given after anesthetic induction/before surgical incision. | Drug: intravenous acetaminophen<br>* experimental(post): administration of IV acetaminophen<br>|
| Placebo Comparator: Placebo comparator : placebo<br>Participants will receive 1.5ml/kg placebo (0.9% saline) before and after surgery and the same dose will be given postoperatively at 8hour intervals for 24hours. | Drug: Placebo<br>* placebo comparator: administration of normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic consumption | Comparison of total analgesic consumption between 3 groups in morphine equivalent | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic consumption | Comparison of total analgesic consumption between 3 groups in morphine equivalent | 48 hours after surgery | 
| Post operative pain scores | Comparison of NRS(numerical rating scale: 0, no pain, 10, worst possible pain) between 3 groups: Worst (cough) and mean pain scores | 4, 8, 24, 48 hours after surgery | 
| Frequency of side effects of opioids | respiratory depression, postoperative nausea/vomiting, itching, constipation | 24, 48, 72 hours after surgery | 
| Quality of recovery questionaire | self reported Quality of recovery-15 (QoR-15: 0, very poor recovery, 150, excellent recovery) questionnaire | 3 to 5 days after surgery | 
| Postoperative recovery | Timing of oral intake(hr), timing of ambulation(hr) | from end of surgery to discharge from hospitalization (average 7 days) | 
| Length of hospital day | postoperative hospital stay(days), intensive care unit admission(days) | from end of surgery to discharge from hospitalization (average 7 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scoliosis, acetaminophen