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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.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (Pre): Acetaminophen | Experimental | 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. |
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| Experimental(post): Acetaminophen | Experimental | 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. |
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| Placebo comparator : placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous acetaminophen | Drug | experimental(pre): administration of IV acetaminophen |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesic consumption | Comparison of total analgesic consumption between 3 groups in morphine equivalent | 24 hours after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Uk Koh, M.D, Ph.D | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26035501 | Background | Shastri N. Intravenous acetaminophen use in pediatrics. Pediatr Emerg Care. 2015 Jun;31(6):444-8; quiz 449-50. doi: 10.1097/PEC.0000000000000463. | |
| 28564673 | Background | Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898. |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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The designated research pharmacist will prepare the both study drug (IV acetaminophen) and placebo and will dispense the study drug according to treatment allocation. Treatment allocation will remain concealed from all other investigators involved in the conduct and analysis of the trial. All other medical staff involved in patient care during the hospital stay of study participant and the study participants itself along with guardians will be also blinded throughout.
| intravenous acetaminophen | Drug | experimental(post): administration of IV acetaminophen |
|
| Placebo | Drug | placebo comparator: administration of normal saline |
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| 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) |
| 23299606 | Background | Ceelie I, de Wildt SN, van Dijk M, van den Berg MM, van den Bosch GE, Duivenvoorden HJ, de Leeuw TG, Mathot R, Knibbe CA, Tibboel D. Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial. JAMA. 2013 Jan 9;309(2):149-54. doi: 10.1001/jama.2012.148050. |
| 38383005 | Derived | Kim YJ, Kim HJ, Kim S, Kim H, Lee CS, Hwang CJ, Cho JH, Ro YJ, Koh WU. Comparison of preemptive and preventive intravenous acetaminophen on opioid consumption in pediatrics undergoing posterior spinal fusion surgery: a randomized controlled trial. Korean J Anesthesiol. 2024 Jun;77(3):326-334. doi: 10.4097/kja.23747. Epub 2024 Feb 20. |