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This prospective randomized controlled study will be conducted to evaluate the effects of preoperative oral magnesium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. Magnesium is a non-anesthetic N-methyl-D-aspartate receptor antagonist, which is as an anesthetic- and analgesic-sparing medication, with controversial clinical effectiveness. Regarding its use as a preventive measure against emergence agitation in children, only intraoperative intravenous route was studied and the results of previous reports were inconsistent. Oral magnesium syrup is a common drug used for enzyme activation, muscle and bone health, with calming effect and central nervous system supporting value.
In this novel study, the investigators will use magnesium via oral route before surgery as they hypothesize that the pre-emptive administration of the drug may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation, the calming effect, sleep promoting value of oral magnesium that may be obtained before anesthetic induction together with its peri-operative analgesic effects may explain its prophylactic benefit against emergence agitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnesium group | Experimental | cases will receive preoperative oral magnesium dose of 120 mg at one hour before surgery |
|
| Control group | Placebo Comparator | cases will receive oral lemon juice at one hour before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium | Drug | preoperative oral magnesium dose of 120 mg at one hour before surgery will be given. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of emergence agitation | Pediatric Anesthesia Emergence Delirium scale scores will be used and a score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. It will be assessed on arrival to the post anesthesia care unit (PACU), and every 15 min thereafter for 1 hour | Up to 1 hour after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Parental separation anxiety | It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured, but not clinging to parents; and 4 signifies crying and clinging to parents. A score of 1 or 2 will be considered as 'acceptable' separation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | Gharbia Governorate | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author
The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
The data will be available upon a reasonable request from the corresponding author
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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 |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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Parallel assignment
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double blinded
| Placebo control | Other | preoperative oral lemon juice at one hour before surgery will be given. |
|
| Perioperative |
| Mask Acceptance Score | Ease of mask acceptance will be graded using the Mask Acceptance Score. It is a 4-point scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A score of 1 or 2 will be considered 'satisfactory' mask acceptance | Perioperative |
| Postoperative pain | the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at PACU arrival and every 0.25 hour for 1 hour after surgery. A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl. | Up to 1 hour after surgery. |
| Total dose of rescue fentanyl | Fentanyl will be given for agitation or pain | Up to 1 hour after surgery. |
| Pediatric Anesthesia Emergence Delirium scale scores | severity of agitation will be assessed by Pediatric Anesthesia Emergence Delirium scale. | Up to 1 hour after surgery. |
| Number of patients who will develop postoperative nausea and vomiting. | Any episodes of nausea and vomiting will be recorded. | Up to 2 hours after surgery. |
| 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 |
| D008670 |
| Metals |