A Phase 4 interventional study of midazolam and alfentanil in Emergence Agitation, sponsored by Yeditepe University Hospital. Completed at 1 site in Turkey. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2013-12-30.
Sponsored by Yeditepe University Hospital · Phase 4, Interventional, and Prevention
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.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 78 is below the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Yeditepe University Hospital is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
Drug: midazolam · Drug: alfentanil
Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)
Drug: midazolam · Drug: ketamine
Midazolam 0.5mg/kg
Drug: midazolam
Group M
Group MA
Group MK
Pediatric Anesthesia Emergence Delirium (PAED) score
Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score
Time frame: 7 months
Parental separation score
Parental separation were evaluated with a 4- point scale in the preoperative period
Time frame: 7 months
Mask acceptance
The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period
Time frame: 7 months
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yeditepe University Hospital