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AgitationPhase 4NCT05273671

Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics

A Phase 4 study testing Nalbuphine, Dexmedetomidine and normal Saline in people with Agitation, run by Alexandria University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 3 to 6 years
Conditions the study is for
Agitation
What is being tested?
Nalbuphine, Dexmedetomidine and normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
1 siteEgypt
Study dates
1 Mar 2022to 2 Jun 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Alexandria university

    Alexandria, 0203

    Mohamed M osman, 01006357996, yasseralx@hotmail.com

    Yasser m osman, assist prof

    Recruiting

Other trials in Egypt

About this study

Official title: 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

Read the 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:

Conditions
Agitation
Being tested
Nalbuphine, Dexmedetomidine, normal Saline
Medical subject headings
Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NalbuphineDrug

    Also called nalophen

    will receive 0.1 mg/kg NAL diluted in 10 ml I.V 10 minutes before the end of surgery

  • DexmedetomidineDrug

    Also called Precedex

    will receive dexmedetomedine 0.5 mic/kg diluted in 10 ml I.V 10 minutes before the end of surgery

  • normal SalineDrug

    Also called saline

    will receive with a saline solution 10 min before the end of surgery

Study groups in NCT05273671
Study groupRoleWhat they receive
nalbuphineExperimental0.1 mg/kg nalbuphine diluted in 10 ml I.V 10 minutes before the end of surgery
Receives: Drug: Nalbuphine
dexmedetomedineExperimentalreceive dexmedetomedine 0.5 mic/kg diluted in 10 ml I.V 10 minutes before the end of surgery
Receives: Drug: Dexmedetomidine
salinePlacebo comparatorreceive a saline solution 10 min before the end of surgery
Receives: Drug: normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at 5, 10, 20 and 30 minutes post-operatively

  2. pediatric anesthesia emergence delirium (PAED) scale change

    pediatric anesthesia emergence delirium (PAED) scale, scale that define the child's behavior in the recovery room

    1. sleeping (best)
    2. awake, calm
    3. irritable, crying
    4. inconsolable crying (worse)

    Measured: at 5, 10, 20 and 30 minutes post-operatively

Secondary outcomes (1)
  1. The time of first postoperative analgesic dose

    in minutes

    Measured: up to 24 hours post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2022
  2. Study start1 Mar 2022
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion2 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05273671
Sponsor's protocol ID
0305447
Status last verified
Feb 2022
First submitted
19 Feb 2022
Last updated
8 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nalbuphine, Dexmedetomidine and normal Saline in people with Agitation, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yasser M osman (+201006357996, yasseralx@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) change (time frame: at 5, 10, 20 and 30 minutes post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.

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