Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric

Emergence Delirium Clinical Trial

Official title:

Effect of Intravenous Nalbuphine Versus Magnesium Sulfate on Emergence Agitation in Pediatric Patients Scheduled for Hypospadias Repair

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06306040
• Other study ID #: Analgesia effect as on EA
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2, 2024
• Est. completion date: January 30, 2025

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Fatma Alzahraa M Mustafa Abdulbari, resident
• Phone: 00201014363853
• Email: zahraamustafa22[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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: - Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias. - Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score - Parental satisfaction scores

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: January 30, 2025
• Est. primary completion date: November 3, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:

• • Weight: 10 - 38 kg.
• Age: 3-7 years.
• ASA physical status: I-II.
• Operation: elective hypospadias repair under general anesthesia

Exclusion Criteria:

• • Parent's refusal.
• Anticipated difficult airway.
• Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia.
• History of developmental delay or mental retardation or any neurological disease.
• Known hypersensitivity to any drug used in this study.
• Children with co-morbid conditions like congenital heart disease, respiratory pathology, central nervous system disorders or renal pathology

Related Conditions & MeSH terms

• Emergence Delirium

Intervention

Drug:
• Nalbuphine Versus Magnesium Sulfate
Nalbuphine is a synthetic opioid receptor agonist-antagonist (agonist ? 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (24)

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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. — View Citation

Jalili S, Esmaeeili A, Kamali K, Rashtchi V. Comparison of effects of propofol and ketofol (Ketamine-Propofol mixture) on emergence agitation in children undergoing tonsillectomy. Afr Health Sci. 2019 Mar;19(1):1736-1744. doi: 10.4314/ahs.v19i1.50. — View Citation

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Kim J, Byun SH, Kim JW, Kim JY, Kim YJ, Choi N, Lee BS, Yu S, Kim E. Behavioral changes after hospital discharge in preschool children experiencing emergence delirium after general anesthesia: A prospective observational study. Paediatr Anaesth. 2021 Oct;31(10):1056-1064. doi: 10.1111/pan.14259. Epub 2021 Aug 6. — View Citation

Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22. — View Citation

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Xie M, Li XK, Peng Y. Magnesium sulfate for postoperative complications in children undergoing tonsillectomies: a systematic review and meta-analysis. J Evid Based Med. 2017 Feb;10(1):16-25. doi: 10.1111/jebm.12230. — View Citation

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Zhang YZ, Wei XL, Tang B, Qin YY, Ou M, Jiang XH, Tan YF, Ye MY. The Effects of Different Doses of Alfentanil and Dexmedetomidine on Prevention of Emergence Agitation in Pediatric Tonsillectomy and Adenoidectomy Surgery. Front Pharmacol. 2022 Feb 2;13:648802. doi: 10.3389/fphar.2022.648802. eCollection 2022. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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