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Effect of Intravenous Nalbuphine on Emergence Agitation

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ClinicalTrials.gov Identifier: NCT03470077
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed abdelhameed, Assiut University

Brief Summary:

Our primary objective of this study is to compare the effect of administration of single dose of intravenous nalbuphine given with induction of anesthesia with intravenous nalbuphine given at the end of surgery on the incidence and severity of EA in children undergoing repair of rupture globe under general anesthesia.

The secondary outcomes will include FLACC score for postoperative pain assessment, hemodynamic variables, any complications as postoperative vomiting (POV) and sedation and parents' satisfaction score.


Condition or disease Intervention/treatment Phase
Postoperative Complications Drug: IV nalbuphine 0.1 mg/kg with induction of anesthesia. Drug: IV nalbuphine 0.1 mg/kg at the end of surgery. Phase 2

Detailed Description:

Postoperative agitation, also referred to as emergence delirium is characterized by mental confusion, irritability, disorientation, inconsolable crying, and increased recovery time in the post anesthesia recovery room, increasing parents' concern and anxiety with respect to the clinical condition of their children . It can also lead to possible injury, damage to surgical dressings, lost intravenous catheters, disconnected cables and monitoring instruments, and source of dissatisfaction for parents, nurses, and others taking care of these children, and hence the children require extra nursing care and supplemental sedative and/or analgesic medications, which may delay patient discharge from hospital and are seven times more likely to have new-onset separation anxiety, apathy, and eating and sleep problems.

It is during the first 30 minutes after emergence that the greatest incidence of agitation is observed, and duration is generally limited and recovery occurs spontaneously. However, prolonged episodes of agitation lasting for up to 2 days have been described.

There is no definitive explanation for emergence agitation (EA). Many different causes have been suggested, such as rapid return of consciousness in an unfamiliar environment, the presence of pain (wounds, sore throat, and bladder distension), stressful induction, airway obstruction, a noisy environment, the duration of anesthesia, the child's personality, anesthetic premedication and the anesthetic technique used.

While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of EA in both adults and children . Children undergoing strabismus surgery under sevoflurane anesthesia often experience EA and postoperative vomiting (POV) .

Multiple medications including ketamine, propofol, clonidine, midazolam and fentanyl have been used effectively to prevent EA. However, these medications may increase sedation after anesthesia, cause slow awakening, and in some cases are associated with undesirable side effects, such as nausea and vomiting.

Nalbuphine is a synthetic opioid κ-receptor agonist μ-receptor antagonist with onset of action occurring within 2-3 min following IV injection, duration of analgesia of 3-6 hours and plasma half-life of 5 hours. Its analgesic potency approximately equals to morphine with less effects on cardiovascular and respiratory system, i.e., nalbuphine causes less intensive and less frequent decrease in blood pressure and respiratory depression.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomly allocated into two groups of 40 patients each:

Group A: will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia. Group B: will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.

Masking: Double (Participant, Investigator)
Masking Description: The trial will be planned that neither the doctors (investigators) nor the patients' guardians or even children themselves will be aware of the group allocation and timing of drug received
Primary Purpose: Prevention
Official Title: Effect of Intravenous Nalbuphine on Emergence Agitation in Children Undergoing Repair of Rupture Globe
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Group A
40 randomly allocated Patients undergoing repair of rupture globe will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia.
Drug: IV nalbuphine 0.1 mg/kg with induction of anesthesia.

Group A: 40 patients will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia.

.

Other Name: nalufin

Experimental: Group B
40 randomly allocated Patients undergoing repair of rupture globe.will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.
Drug: IV nalbuphine 0.1 mg/kg at the end of surgery.
Group B: 40 patients will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.
Other Name: nalufin




Primary Outcome Measures :
  1. The incidence of Emergence Agitation in children undergoing repair of rupture globe under general anesthesia [ Time Frame: at the first 30 minutes after surgery ]

    the Incidence of Emergence Agitation will be evaluated using Aono's four-point scale.

    • minimum score: 1
    • maximum score:4 Scores of one and two were considered as absence of EA, and scores of 3 and 4 were analyzed as presence of Emergence Agitation.

      1. Calm
      2. Not calm, but could be easily calmed
      3. Moderately agitated or restless
      4. Combative, excited, disoriente


Secondary Outcome Measures :
  1. The severity of Emergency Agitation [ Time Frame: at the first 30 minutes after surgery ]
    5- The severity of EA will be evaluated using the pediatric anesthesia emergence delirium scale A perfectly calm child scores 0 and extreme agitation corresponds to 20 points Agitation scores less than 10 will be interpreted as an absence of agitation, scores ≥ 10 will be regarded as presence of agitation, and scores ≥15 will be regarded as severe agitation

  2. postoperative vomiting [ Time Frame: first 48 hours after surgery ]

    Postoperative vomiting will be assessed using a numeric rank score

    • minimum score: 0
    • maximum score: 2 higher values represent a worse outcome and lowest values represent a better outcome 0 = no vomiting, 1 = vomited once, and 2 = vomited twice or more.

  3. Postoperative sedation [ Time Frame: first 48 hours after surgery ]

    Postoperative sedation will be assessed using sedation score described by Culebras et al (2001)

    • minimum score: 1
    • maximum score: 5 higher values represent a worse outcome and lowest values represent a better outcome 1. Awake and alert. 2. Sleeping but easily arouses to voice or light touch. 3. Arouses to loud voice or shaking. 4. Arouses with painful stimuli only. 5. Unarousable).

  4. Postoperative FLACC Pain Score [ Time Frame: first 24 hours after surgery ]
    Face, Legs, Activity, Cry, and Consolability (FLACC) pain score



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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: 3-8 years.
  • American Society of Anesthesiologists (ASA) physical status I-II scheduled to undergo repair of rupture globe.
  • Gender: both.

Exclusion Criteria:

  • Parent refusal.
  • History of developmental delay or mental retardation.
  • Known hypersensitivity to any drug used in this study.
  • Children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470077


Contacts
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Contact: Mohamed Abdelhameed, M.M.B.CH 01144431446 Hamedo_2020@yahoo.com
Contact: Ragaa Ahmed, Lecturer 01001741748 ragaanesthesia@yahoo.com

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Hamdy Abbas, Professor Assiut University
Publications:
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Responsible Party: Mohamed abdelhameed, M.M.B.CH& Resident Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03470077    
Other Study ID Numbers: postoperative EA in children
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergence Delirium
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Neurobehavioral Manifestations
Delirium
Confusion
Neurocognitive Disorders
Mental Disorders
Nalbuphine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents