Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics

Comparison Between Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics During Sevoflurane Anesthesia: Prospective Randomized Controlled Clinical Trial

the investigators hypothesized that Nalbuphine may be alternative pharmacological agent for prevention of emergence agitation in pediatrics who will be scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) during sevoflurane anesthesia

Study Overview

• Status: Recruiting
• Conditions: Agitation
• Intervention / Treatment: Drug: Nalbuphine; Drug: Dexmedetomidine; Drug: normal Saline

Detailed Description

SEVOFLURANE is widely used popular inhalational anesthetic to induce and maintain anesthesia in children due to its greater hemodynamic stability, less irritation of the airway and low blood gas solubility coefficient, which causes rapid emergence and recovery from general anesthesia in pediatric anesthesia. [1] However, sevoflurane anesthesia is frequently associated with emergence agitation (EA) in children with incidence ranging up to 80%. [2-5] EA is a complex phenomenon and a variety of explanations have been proposed for its etiology. These include multiple surgical and patient related factors as well as anesthesia related factors such as rapid emergence due to the low blood solubility of sevoflurane.[1,2,6] Despite it is usually self limited; EA is still a considerable side-effect because of the risks of falling, self-injury to the child or to the surgical site, the stress caused to both caregivers and families, moreover, increase the need for continuous monitoring of patients by recovery room staffs and physical restraint of patient.[6] Several medications like propofol, fentanyl, a2-adrenergic receptor agonist and ketamine have been investigated in an attempt to reduce the occurrence and severity of EA, with variable outcomes. [4-11] Dexmedetomidine is an a-2 adrenergic agonist with a larger ratio of a2/a1 activity (1600:1) when compared to clonidine (200:1).The hemodynamic effects of dexmedetomidine are similar to that of clonidine and the effects can vary depending on the dose, rat. [10] Nalbuphine (NAL) is a synthetic opioid agonist antagonist acts on kappa and mu opioid receptor producing analgesia and sedation .One of the advantages of NAL over pure narcotic agonists is inducing minimal respiratory depression, it is considered a safe drug and the large margin of safety make it often used for pediatric patients. It has been shown that the use of nalbuphine carries a lower risk of adverse events like nausea, vomiting, pruritus, constipation, and respiratory depression Our primary outcome: The incidence of post-operative EA Secondary outcome:Time to emergence in minutes Time to extubation in minutes Children's hospital eastern Ontario pain scale. Discharge time (min) The time of first postoperative analgesic dose Possible postoperative side effects. All patients will undergo thorough preoperative evaluation, which include history, physical examination and relevant laboratory investigations. None of the patients will be given any solid food for 6 hours preoperatively but each will be encouraged to take clear fluids until 2 hours before induction of anesthesia. All patients will be pre-medicated with 0.3 mg/kg oral midazolam (maximum dose of 12 mg) 30 min before induction. Upon arrival at the operating room, patients will be monitored by non-invasive the blood pressure, temperature, electrocardiogram capnography and pulse oximetry.

Inhalation induction will be done via transparent face mask after saturating the breathing system (Jackson-Rees modification of Ayer's T-piece) with a mixture of sevoflurane 8 vol % in 100% O2 (6 L/min). After loss of consciousness, intravenous line will be inserted and Rocuronium 0.6 mg/kg is administered and when adequate depth of anesthesia is reached, a laryngeal mask airway (LMA) of appropriate size for the age and weight of the child will be placed .Anesthesia will maintained with sevoflurane at 2 3 vol % in 40% O2 in air to maintain a stable heart rate, blood pressure and respiratory rate (base line ± 20%). Paracetamol 15 mg/kg (Perfalgan® 100 ml vial UPSA France) and Dexamethasone 0.3 mg/kg will be administered IV to each child immediately after the induction of anesthesia. Lung ventilation will be controlled to maintain the end tidal carbon dioxide tension between 30 and 35 mmHg. Caudal block with 1.0 ml/kg 0.25% bupivacaine will be performed in all patients. Failure of caudal block will be defined as increase in heart rate and or mean arterial blood pressure (MAP) > 10% than pre-incisional value at the start of surgery. No opioid will be given; no propofol will be used during the procedure.

The allocated children will be randomly assigned through computer-generated random numbers contained in sealed opaque envelopes to one of the three groups:

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 0203
    • Recruiting
    • Alexandria University
    • Principal Investigator: Yasser m osman, assist prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I &II
• scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) under general anesthesia

Exclusion Criteria:

• history of hypersensitivity to the studied drug,
• refusal of the legal guardian
• chronic or acute intake of any sedative or analgesic drugs,
• Psychological& emotional disorder.
• Cognitive or developmental disorders.
• severely agitated child at induction of anesthesia
• Any neurological condition that would limit the patient's ability to communicate with or understand nursing personnel,
• Existing contraindications to caudal block such as coagulopathy, local and systemic infection.
• Failure of the caudal block.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nalbuphine; 0.1 mg/kg nalbuphine diluted in 10 ml I.V 10 minutes before the end of surgery	Drug: Nalbuphine; will receive 0.1 mg/kg NAL diluted in 10 ml I.V 10 minutes before the end of surgery; Other Names: nalophen
Experimental: dexmedetomedine; receive dexmedetomedine 0.5 mic/kg diluted in 10 ml I.V 10 minutes before the end of surgery	Drug: Dexmedetomidine; will receive dexmedetomedine 0.5 mic/kg diluted in 10 ml I.V 10 minutes before the end of surgery; Other Names: Precedex
Placebo Comparator: saline; receive a saline solution 10 min before the end of surgery	Drug: normal Saline; will receive with a saline solution 10 min before the end of surgery; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) change	Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) based on crying, facial expression, verbal statements, position of torso, touching of the wound and movement of legs will be used for post-operative pain assessment; minimum score: 4 best; maximum score: 13 worse	at 5, 10, 20 and 30 minutes post-operatively
pediatric anesthesia emergence delirium (PAED) scale change	pediatric anesthesia emergence delirium (PAED) scale, scale that define the child's behavior in the recovery room; sleeping (best); awake, calm; irritable, crying; inconsolable crying (worse)	at 5, 10, 20 and 30 minutes post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of first postoperative analgesic dose	in minutes	up to 24 hours post operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of side effects in PACU like nausea and vomiting.	incidence and severity	up to 24 hours post operative

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: yasser M osman, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 2, 2022

Study Registration Dates

• First Submitted: February 19, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Dexmedetomidine; Nalbuphine
• Other Study ID Numbers: 0305447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No