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

March 8, 2024 updated by: Fatma alzahraa Mustafa Abdelbary Thabet, Assiut University

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

• 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Abualauon Mohamed M Abdelmohsen Rashwan, Lecturer
  • Phone Number: 01094131398
  • Email: abualauon@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: • Group N (Nalbuphine group n=35 )
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

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.

Other Names:
  • analgesic effect on emergency agitation
Experimental: • Group M (Magnesium sulfate group n=35 )
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

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.

Other Names:
  • analgesic effect on emergency agitation
Experimental: Group C (Control group n=35 ):
administrate 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
Drug: Nalbuphine Versus Magnesium Sulfate

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.

Other Names:
  • analgesic effect on emergency agitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare between analgesia effect on pediatric patient
Time Frame: baseline
Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Abualauon M Mohamed Abdelmohsen Rashwan, Lecturer, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 2, 2024

Primary Completion (Estimated)

November 3, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Analgesia effect as on EA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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