Sevoflurane Induced Emergence Agitation

Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02022488

Enrollment

Registered

2013-12-27

Start date

2012-02-29

Completion date

2012-08-31

Last updated

2013-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Agitation

Keywords

Child, Sevoflurane, Emergence delirium, General anesthesia, Premedication.

Brief summary

Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.

Interventions

DRUGmidazolam

Group M

DRUGalfentanil

Group MA

DRUGketamine

Group MK

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 8 Years

Healthy volunteers

Inclusion criteria

* 1- 8 years * American Society of Anesthesiologist (ASA) I-II, * Patients undergoing procedures below the umbilicus

Exclusion criteria

* cardiac diseases * pulmonary diseases * hepatic diseases * renal diseases * psychological or emotional disorders

Design outcomes

Primary

Measure	Time frame	Description
Pediatric Anesthesia Emergence Delirium (PAED) score	7 months	Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score

Secondary

Measure	Time frame	Description
Parental separation score	7 months	Parental separation were evaluated with a 4- point scale in the preoperative period
Mask acceptance	7 months	The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026