Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score
Sevoflurane Induced Emergence Agitation
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.
Intervention / Treatment
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Midazolam (DRUG)Group M
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Alfentanil (DRUG)Group MA
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Ketamine (DRUG)Group MK
Condition or Disease
- Emergence Agitation
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 1 Year to 8 Years |
Enrollment: | 78 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Prevention |
MaskingTRIPLE:
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Clinical Trial Dates
Start date: | Feb 01, 2012 | |
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Primary Completion: | Aug 01, 2012 | ACTUAL |
Completion Date: | Aug 01, 2012 | ACTUAL |
Study First Posted: | Dec 27, 2013 | ESTIMATED |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Dec 26, 2013 |
Sponsors / Collaborators
Lead Sponsor:
Yeditepe University Hospital
Responsible Party:
N/A
Location
Participant Groups
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Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
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Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)
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Midazolam 0.5mg/kg
Eligibility Criteria
Sex: | All |
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Minimum Age: | 1 |
Maximum Age: | 8 |
Age Groups: | Child |
Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
Secondary Outcomes
-
Parental separation were evaluated with a 4- point scale in the preoperative period
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The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period
More Details
NCT Number: | NCT02022488 |
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Other IDs: | 162 |
Study URL: | https://clinicaltrials.gov/study/NCT02022488 |
Last updated: Sep 29, 2023