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• Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.
• Secondary outcome:
Emergence agitation (EA), also referred to as emergence delirium, emergence excitement or inadequate emergence, is a frequent post-operative complication in pediatric patients receiving inhalational anesthetics. It's defined as an acute and fluctuating alteration of mental state and manifesting as agitation, confusion, disorientation, and hyperactivity during the transition from unconsciousness to full wakefulness. The incidence of EA is reported to be up to 20% in adult patients and up to 80% in children.
Although EA is self-limiting, it can induce potential problems in children, such as self-injury, bleeding and cracking of the wound, falling off of the indwelling catheter, and falling off of the bed, which can cause some difficulties for medical staff and serious anxiety for family members. In addition, children with EA are at a higher risk of post-hospitalization behavioral changes, which may last longer. Furthermore, EA treatment increases the burden on healthcare providers and increases the medical expenses of patients. EA commonly occurs after the most common surgeries in children like adenoidectomy, tonsillectomy, hernioplasty and hypospadias repair. Therefore, implementing effective measures to prevent EA in children undergoing these types of surgeries is crucial. Although the underlying mechanisms of EA remain unclear, the mechanisms may be related to pre-operative anxiety, inhaled anesthetics (sevoflurane or desflurane), surgery type (ophthalmology or otolaryngology procedure), and younger age.
Some pharmacological interventions have been used to prevent and treat EA. Previous studies have demonstrated that propofol, benzodiazepines, α2 agonists, and opioids can prevent EA in children to varying degrees. However, these medications may lead to respiratory depression, delay in anesthesia recovery and post-anesthesia care unit stay, and other adverse reactions. Thus, the most favorable prophylactic treatment to decrease such an incidence remains unknown, and the ideal approaches to prevent EA merit further exploration.
Nalbuphine is a synthetic opioid receptor agonist-antagonist (agonist К receptor, antagonistic part μ receptor) that can produce a central analgesic effect and partial sedation. Nalbuphine is a medication that is indicated for moderate to severe pain where the patient requires an opioid agent, and other alternative treatments have been insufficient. The inhibitory effect of nalbuphine on respiration is slight and it has a capping effect. Owing to these advantages, it is widely used in pediatric surgical analgesia.
Magnesium sulphate, an antagonist of N-methyl-D-aspartate (NMDA) glutamate receptors, has been reported to improve hypo-magnesia and pre-eclampsia. Recently, magnesium sulphate has been gradually used as an adjuvant for sedation and analgesia during general anesthesia. Magnesium sulphate is a medication used to manage and treat multiple clinical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| • Group N (Nalbuphine group n=35 ) | Experimental | administrate nalbuphine 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery (injected once) dose |
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| • Group M (Magnesium sulfate group n=35 ) | Experimental | administrate magnesium sulfate once 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery |
|
| Group C (Control group n=35 ): | Experimental | administrate 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine Versus Magnesium Sulfate | Drug | Nalbuphine is a synthetic opioid receptor agonist-antagonist (agonist К receptor, antagonistic part μ receptor) that can produce a central analgesic effect and partial sedation. Nalbuphine is a medication that is indicated for moderate to severe pain where the patient requires an opioid agent, and other alternative treatments have been insufficient. The inhibitory effect of nalbuphine on respiration is slight and it has a capping effect. Owing to these advantages, it is widely used in pediatric surgical analgesia. Magnesium sulphate, an antagonist of N-methyl-D-aspartate (NMDA) glutamate receptors, has been reported to improve hypo-magnesia and pre-eclampsia. Recently, magnesium sulphate has been gradually used as an adjuvant for sedation and analgesia during general anesthesia. Magnesium sulphate is a medication used to manage and treat multiple clinical conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| compare between analgesia effect on pediatric patient | Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales. | baseline |
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Inclusion Criteria:
• Weight: 10 - 38 kg.
Exclusion Criteria:
• Parent's refusal.
name of patient gender exposure on surgery only male participants are being due to surgery is hypospadias repair.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma Alzahraa M Mustafa Abdulbari, resident | Contact | 00201014363853 | zahraamustafa22@yahoo.com | |
| Abualauon Mohamed M Abdelmohsen Rashwan, Lecturer | Contact | 01094131398 | abualauon@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Abualauon M Mohamed Abdelmohsen Rashwan, Lecturer | Assiut University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32209961 | Background | Lee SJ, Sung TY. Emergence agitation: current knowledge and unresolved questions. Korean J Anesthesiol. 2020 Dec;73(6):471-485. doi: 10.4097/kja.20097. Epub 2020 Mar 25. | |
| 20047899 | Background | Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3. |
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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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| 31190751 | Background | Kawai M, Kurata S, Sanuki T, Mishima G, Kiriishi K, Watanabe T, Ozaki-Honda Y, Yoshida M, Okayasu I, Ayuse T, Tanoue N, Ayuse T. The effect of midazolam administration for the prevention of emergence agitation in pediatric patients with extreme fear and non-cooperation undergoing dental treatment under sevoflurane anesthesia, a double-blind, randomized study. Drug Des Devel Ther. 2019 May 17;13:1729-1737. doi: 10.2147/DDDT.S198123. eCollection 2019. |
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| 16490089 | Background | Malviya S, Voepel-Lewis T, Burke C, Merkel S, Tait AR. The revised FLACC observational pain tool: improved reliability and validity for pain assessment in children with cognitive impairment. Paediatr Anaesth. 2006 Mar;16(3):258-65. doi: 10.1111/j.1460-9592.2005.01773.x. |
| 10320170 | Background | White PF, Song D. New criteria for fast-tracking after outpatient anesthesia: a comparison with the modified Aldrete's scoring system. Anesth Analg. 1999 May;88(5):1069-72. doi: 10.1097/00000539-199905000-00018. No abstract available. |
| 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 |