Use of Intravenous Acetaminophen in Pediatrics Undergoing Spinal Fusion Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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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The decrease in postoperative analgesic requirement following IV acetaminophen
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The decrease in intensity of postoperative pain following IV acetaminophen
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The quality of recovery including self-reported recovery, physical and functional recovery and length of stay
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The preemptive analgesic effect of IV acetaminophen
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental (Pre): Acetaminophen 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
experimental(pre): administration of IV acetaminophen
|
| Experimental: Experimental(post): Acetaminophen 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
experimental(post): administration of IV acetaminophen
|
| Placebo Comparator: Placebo comparator : placebo 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
placebo comparator: administration of normal saline
|
Outcome Measures
Primary Outcome Measures
- Postoperative analgesic consumption [24 hours after surgery]
Comparison of total analgesic consumption between 3 groups in morphine equivalent
Secondary Outcome Measures
- Postoperative analgesic consumption [48 hours after surgery]
Comparison of total analgesic consumption between 3 groups in morphine equivalent
- Post operative pain scores [4, 8, 24, 48 hours after surgery]
Comparison of NRS(numerical rating scale: 0, no pain, 10, worst possible pain) between 3 groups: Worst (cough) and mean pain scores
- Frequency of side effects of opioids [24, 48, 72 hours after surgery]
respiratory depression, postoperative nausea/vomiting, itching, constipation
- Quality of recovery questionaire [3 to 5 days after surgery]
self reported Quality of recovery-15 (QoR-15: 0, very poor recovery, 150, excellent recovery) questionnaire
- Postoperative recovery [from end of surgery to discharge from hospitalization (average 7 days)]
Timing of oral intake(hr), timing of ambulation(hr)
- Length of hospital day [from end of surgery to discharge from hospitalization (average 7 days)]
postoperative hospital stay(days), intensive care unit admission(days)
Eligibility Criteria
Criteria
Inclusion Criteria:
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American Society of Anesthesiologists (ASA) physical status 1-3
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patients undergoing spinal fusion surgery
Exclusion Criteria:
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patients who refuse to participate in this study
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patients unable to communicate due to mental impairment or developmental delay
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patients allergic to acetaminophen or its additives or who are contraindicated in acetaminophen administration for other reasons
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patients with existing liver diseases or dysfunction (i.e. active hepatitis, clinically relevant chronic liver conditions, elevated liver enzymes)
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patients who are judged ineligible by the medical staff to participate in the study for other reasons
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asan Medical Center | Seoul | Korea, Republic of | 05505 |
Sponsors and Collaborators
- Asan Medical Center
Investigators
- Principal Investigator: Won Uk Koh, M.D, Ph.D, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Ceelie I, de Wildt SN, van Dijk M, van den Berg MM, van den Bosch GE, Duivenvoorden HJ, de Leeuw TG, Mathôt 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.
- Shastri N. Intravenous acetaminophen use in pediatrics. Pediatr Emerg Care. 2015 Jun;31(6):444-8; quiz 449-50. doi: 10.1097/PEC.0000000000000463. Review.
- 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. Review.
- 2021-0411