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

Table 2 Study schedule of assessments (age ≤ 7 years old)

Item	Screening	Follow-up
	V0	V1						V2		V3
	Preoperative	Preoperative	Intraoperative	Postoperative				Postoperative		Postoperative
	−7–0 days	Preoperative	Intraoperative	10 min	20 min	30 min	2 h	4 h	24 h±3 h	48 h±3 h
Signing informed consent form	√
Randomization		√
Basic information	√
Inclusion/exclusion criteria	√
Basic medical history	√
Surgical information	√		√
vital signs	√	√	√
Laboratory examination	√								*	*
ECG examination	√								*	*
FLAAC score	√			√	√	√	√	√	√	√
Analgesic dosage			√						√	√
PEAD evaluation				√	√	√
Concomitant medication	√		√						√	√
AEs			√	√	√	√	√	√	√	√
SAEs			√	√	√	√	√	√	√	√

ECG electrocardiogram, FLAAC Face Legs Activity Cry and Consolability, PEAD Pediatric Anesthesia Emergence Delirium, AEs adverse events, SAEs serious adverse events
√: required; ^*: optional
Laboratory examination: blood routine, blood biochemical index, urine routine, and coagulation function

ISSN: 1745-6215