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 3 Study schedule of assessments (8 ≤ age ≤ 17 years old)

Item	Screening	Follow-up
	V0	V1				V2	V3
	Preoperative −7–0 days	Preoperative	Intraoperative	Postoperative		Postoperative	Postoperative
	Preoperative −7–0 days	Preoperative	Intraoperative	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	√					*	*
NRS score	√			√	√	√	√
Analgesic dosage			√			√	√
Depression/anxiety evaluation^#	√						√
Concomitant medication	√		√			√	√
AEs		√	√	√	√	√	√
SAEs		√	√	√	√	√	√

ECG electrocardiogram, NRS Numeric Rating Scale, AEs adverse events, SAEs serious adverse events
√: required; ^*: optional
Laboratory examination: blood routine, blood biochemical index, urine routine, and coagulation function
^#: 8 ≤ age ≤ 13 years old, depression/anxiety will be assessed using the Children’s Depression Inventory (CDI); 14 ≤ age ≤ 17 years old, depression/anxiety will be assessed using the CDI and Hospital Anxiety and Depression Scale (HAD))

ISSN: 1745-6215