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

NCT06306040 | Not Yet Recruiting Phase 3

• 1 other identifier: Analgesia effect as on EA
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

• 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

Drug: Nalbuphine Versus Magnesium Sulfate

• 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

Drug: Nalbuphine Versus Magnesium Sulfate

Group C (Control group n=35 ):

EXPERIMENTAL

administrate 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery

Drug: Nalbuphine Versus Magnesium Sulfate

Interventions

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.

Also known as: analgesic effect on emergency agitation

Group C (Control group n=35 ):; • Group M (Magnesium sulfate group n=35 ); • Group N (Nalbuphine group n=35 )

Eligibility Criteria

• Age: 3 Years - 7 Years
• Gender Eligibility Details: name of patient gender exposure on surgery only male participants are being due to surgery is hypospadias repair.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (24)

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MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Abualauon M Mohamed Abdelmohsen Rashwan, Lecturer

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Fatma Alzahraa M Mustafa Abdulbari, resident

CONTACT

00201014363853; zahraamustafa22@yahoo.com

Abualauon Mohamed M Abdelmohsen Rashwan, Lecturer

CONTACT

01094131398; abualauon@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery * Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery * Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fatma Alzahraa Mustafa Abdelbary - Director

Model Details: * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery * Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery * Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: April 2, 2024
• Primary Completion: November 3, 2024
• Study Completion: January 30, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03