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Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.
Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-nasal Dexmedetomidine | Experimental | Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room. |
|
| Oral Midazolam | Active Comparator | Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-nasal Dexmedetomidine | Drug | Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of pediatric delirium | Time from when the patient is woken from anesthesia to the onset of delirium. | Zero minutes to 48 hours |
| Time to offset of pediatric delirium | Time from onset of delirium to the offset of delirium. | Zero minutes to 48 hours |
| Duration of pediatric delirium | Total time patient experiences delirium | Zero minutes to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Acceptance | The willingness of the subject to take the drug was assessed in the pre-operative area | 10-25 minutes prior to surgery |
| Parental Separation Anxiety Scale (PSAS) | Anxiety score was determined when the child was separated from the parents according to four levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Ian Richmond, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
Data will be shared via publication as group data.
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Randomized control trial
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The surgeon and post-operative nurses will be masked to the group allocation. Masking will only be revealed if medically necessary.
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| Oral Midazolam | Drug | Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. |
|
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| 0-48 hours |
| Mask Acceptance Scale | The child's acceptance of the mask by the anesthesiologist was rated as follows. | 1-10 minutes prior to surgery |
| End tidal Sevoflurane value | During the surgery and at the time when patient leaves the OR End tidal Sevoflurane value will be documented. | 0-12 hours |
| Rescue analgesia in PACU | The amount and dose of oral/rectal acetaminophen given in PACU was recorded. | 0-6 hours post surgery |
| Home Behavior Analysis | The child's parents were given a diary to document their behavior for 48 hours post-operatively at home. | 12-48 hours |
| Oral analgesic use | Document intake of oral analgesics like acetaminophen or ibuprofen | Two days post-operative |
| D001569 |
| Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |