Scoliosis; Adolescence
Conditions
Keywords
scoliosis, acetaminophen
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; 1. The decrease in postoperative analgesic requirement following IV acetaminophen 2. The decrease in intensity of postoperative pain following IV acetaminophen 3. The quality of recovery including self-reported recovery, physical and functional recovery and length of stay 4. The preemptive analgesic effect of IV acetaminophen
Interventions
experimental(pre): administration of IV acetaminophen
DRUGPlacebo
placebo comparator: administration of normal saline
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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
Sex/Gender
ALL
Age
11 Years to 20 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesic consumption | 24 hours after surgery | Comparison of total analgesic consumption between 3 groups in morphine equivalent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 |
| Postoperative analgesic consumption | 48 hours after surgery | Comparison of total analgesic consumption between 3 groups in morphine equivalent |
Countries
South Korea
Outcome results
None listed