Use of Intravenous Acetaminophen in Adolescents and Pediatrics Undergoing Spinal Fusion Surgery: Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Postoperative analgesic consumption
Study Overview
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.
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;
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 11 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: intravenous acetaminophen (Drug)
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.
Intervention: intravenous acetaminophen (Drug)
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.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Postoperative analgesic consumption
Time Frame: 24 hours after surgery
Comparison of total analgesic consumption between 3 groups in morphine equivalent
Secondary Outcomes
- Frequency of side effects of opioids(24, 48, 72 hours after surgery)
- Post operative pain scores(4, 8, 24, 48 hours after surgery)
- Postoperative recovery(from end of surgery to discharge from hospitalization (average 7 days))
- Postoperative analgesic consumption(48 hours after surgery)
- Length of hospital day(from end of surgery to discharge from hospitalization (average 7 days))
- Quality of recovery questionaire(3 to 5 days after surgery)
Investigators
Won Uk, Koh
Associate professor
Asan Medical Center