Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics

NCT05273671 | Unknown Phase 4

• 1 other identifier: 0305447
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Agitation

Outcome Measures

Primary Outcomes (2)

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

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

Secondary Outcomes (1)

• The time of first postoperative analgesic dose

  up to 24 hours post operative

Other Outcomes (1)

• occurrence of side effects in PACU like nausea and vomiting.

  up to 24 hours post operative

Study Arms (3)

nalbuphine

EXPERIMENTAL

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

Drug: Nalbuphine

dexmedetomedine

EXPERIMENTAL

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

Drug: Dexmedetomidine

saline

PLACEBO COMPARATOR

receive a saline solution 10 min before the end of surgery

Drug: normal Saline

Interventions

Nalbuphine DRUG

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

Also known as: nalophen

nalbuphine

Dexmedetomidine DRUG

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

Also known as: Precedex

dexmedetomedine

normal Saline DRUG

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

Also known as: saline

saline

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university

Alexandria, 0203, Egypt

RECRUITING

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Nalbuphine; Dexmedetomidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• yasser M osman

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yasser M osman

CONTACT

+201006357996; yasseralx@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: allocated children will be randomly assigned through computer-generated random numbers contained in sealed opaque envelopes to one of the three groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 10, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 2, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)