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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| midazolam and alfentanil | Active Comparator | Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral) |
|
| midazolam and ketamine | Active Comparator | Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal) |
|
| midazolam | Placebo Comparator | Midazolam 0.5mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| midazolam | Drug | Group M |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Anesthesia Emergence Delirium (PAED) score | Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parental separation score | Parental separation were evaluated with a 4- point scale in the preoperative period | 7 months |
| Mask acceptance | The ease of mask acceptance were evaluated with a 4- point scale in the preoperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeditepe University Hospital | Istanbul | 34752 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D015760 | Alfentanil |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| alfentanil | Drug | Group MA |
|
| ketamine | Drug | Group MK |
|
| 7 months |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |