PMID- 35870990
OWN - NLM
STAT- MEDLINE
DCOM- 20220726
LR  - 20220729
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 23
IP  - 1
DP  - 2022 Jul 23
TI  - Evaluation of the effect of perioperative administration of S(+)-ketamine 
      hydrochloride injection for postoperative acute pain in children: study protocol 
      for a prospective, multicenter, randomized, open-label, parallel-group, pragmatic 
      clinical trial.
PG  - 586
LID - 10.1186/s13063-022-06534-z [doi]
LID - 586
AB  - BACKGROUND: Inadequate postoperative pain management increases the risk of 
      adverse events after the surgery and aggressive perioperative pain prevention has 
      both short-term and long-term benefits. S(+)-ketamine is an N-methyl-D-aspartic 
      acid (NMDA) receptor antagonist with a strong analgesic effect and can 
      significantly relieve postoperative acute pain and reduce opioid consumption. 
      However, for children, it still needs to be confirmed by large sample clinical 
      studies. METHODS: This is a pragmatic, randomized controlled trial which will 
      evaluate the effect of perioperative administration of S(+)-ketamine 
      hydrochloride injection for postoperative acute pain in children in a pragmatic 
      clinical setting. A total of 3000 children (</=17 years old) undergoing surgery 
      will be included in this protocol. Subjects will be randomized 2:1 to either 
      receive S(+)-ketamine hydrochloride injection or conventional therapy without 
      S(+)-ketamine during the entire perioperative period. The primary endpoints are 
      the area under the receiver operating characteristic (ROC) curve of Face Legs 
      Activity Cry and Consolability (FLACC, 0-7 years old) scale score or Numerical 
      Rating Scale (NRS, 8-17 years old) score within 48 h after surgery, and the 
      consumption of opioids within 48 h after surgery. The secondary endpoints include 
      the time of first use of rescue analgesics after surgery, rescue analgesia rate 
      within 48 h after surgery, anesthesia recovery time, incidence of emergency 
      delirium (for 0-7 years old), changes of anxiety and depression scale scores at 
      48 h after surgery (for 8-17 years old), incidence of intraoperative adverse 
      events (AEs), and incidence of postoperative AEs and pharmacoeconomic indicators. 
      AEs and serious AEs were recorded to evaluate safety. DISCUSSION: This trial will 
      be the first pragmatic clinical trial to prospectively assess the effect of 
      perioperative administration of S(+)-ketamine hydrochloride injection for 
      postoperative acute pain in children, which is of great significance to the 
      continuous optimization of clinical anesthesia and analgesia programs for 
      children. TRIAL REGISTRATION: This trial was registered in the U.S. National 
      Institutes of Health ClinicalTrials.gov database ( http://clinicaltrials.gov ; 
      Registration number: NCT04834427). Registered on 8 April 2021.
CI  - (c) 2022. The Author(s).
FAU - Wang, Hong
AU  - Wang H
AD  - Department of Anesthesiology, The First Medical Center of Chinese PLA General 
      Hospital, Beijing, 100853, People's Republic of China.
FAU - Duan, Chongyang
AU  - Duan C
AD  - Department of Biostatistics, School of Public Health, Southern Medical 
      University, Guangzhou, 510515, People's Republic of China.
FAU - Zhang, Jianmin
AU  - Zhang J
AD  - Department of Anesthesiology, Beijing Children's Hospital, Capital Medical 
      University, National Center for Children's Health, Beijing, 100045, People's 
      Republic of China.
FAU - Qu, Shuangquan
AU  - Qu S
AD  - Department of Anesthesiology, Hunan Children's Hospital, Changsha, 410007, 
      People's Republic of China.
FAU - Sun, Ying
AU  - Sun Y
AD  - Department of Anesthesiology, Shanghai Children's Medical Center, School of 
      Medicine, Shanghai Jiao Tong University, Shanghai, 200120, People's Republic of 
      China.
FAU - Zhou, Lizhi
AU  - Zhou L
AD  - Department of Biostatistics, School of Public Health, Southern Medical 
      University, Guangzhou, 510515, People's Republic of China.
FAU - Yang, Lujia
AU  - Yang L
AD  - Department of Anesthesiology, The First Medical Center of Chinese PLA General 
      Hospital, Beijing, 100853, People's Republic of China.
FAU - Lan, Chen
AU  - Lan C
AD  - Department of Anesthesiology, The First Medical Center of Chinese PLA General 
      Hospital, Beijing, 100853, People's Republic of China.
FAU - Mi, Weidong
AU  - Mi W
AD  - Department of Anesthesiology, The First Medical Center of Chinese PLA General 
      Hospital, Beijing, 100853, People's Republic of China. wwdd1962@aliyun.com.
FAU - Chen, Pingyan
AU  - Chen P
AD  - Department of Biostatistics, School of Public Health, Southern Medical 
      University, Guangzhou, 510515, People's Republic of China. chenpy99@126.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT04834427
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20220723
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Analgesics)
RN  - 0 (Analgesics, Opioid)
RN  - 690G0D6V8H (Ketamine)
SB  - IM
MH  - *Acute Pain/diagnosis/drug therapy
MH  - Adolescent
MH  - Analgesics/therapeutic use
MH  - Analgesics, Opioid
MH  - Child
MH  - Child, Preschool
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - *Ketamine/adverse effects
MH  - Multicenter Studies as Topic
MH  - Pain Measurement
MH  - *Pain, Postoperative/diagnosis/drug therapy
MH  - Pragmatic Clinical Trials as Topic
MH  - Prospective Studies
MH  - Randomized Controlled Trials as Topic
PMC - PMC9308221
OTO - NOTNLM
OT  - Acute pain
OT  - Analgesia
OT  - Anesthesia
OT  - Children
OT  - Esketamine
OT  - Ketamine
OT  - Perioperative period
OT  - Postoperative pain
OT  - S(+)-ketamine
OT  - S(+)-ketamine hydrochloride
COIS- The authors declare that they have no competing interests.
EDAT- 2022/07/24 06:00
MHDA- 2022/07/27 06:00
PMCR- 2022/07/23
CRDT- 2022/07/23 23:37
PHST- 2021/12/30 00:00 [received]
PHST- 2022/07/11 00:00 [accepted]
PHST- 2022/07/23 23:37 [entrez]
PHST- 2022/07/24 06:00 [pubmed]
PHST- 2022/07/27 06:00 [medline]
PHST- 2022/07/23 00:00 [pmc-release]
AID - 10.1186/s13063-022-06534-z [pii]
AID - 6534 [pii]
AID - 10.1186/s13063-022-06534-z [doi]
PST - epublish
SO  - Trials. 2022 Jul 23;23(1):586. doi: 10.1186/s13063-022-06534-z.