Effect of Intravenous Nalbuphine on Emergence Agitation

NCT03470077 | Completed Phase 2

• 1 other identifier: postoperative EA in children
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• The incidence of Emergence Agitation in children undergoing repair of rupture globe under general anesthesia

  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

  at the first 30 minutes after surgery

Secondary Outcomes (4)

• The severity of Emergency Agitation

  at the first 30 minutes after surgery

• postoperative vomiting

  first 48 hours after surgery

• Postoperative sedation

  first 48 hours after surgery

• Postoperative FLACC Pain Score

  first 24 hours after surgery

Study Arms (2)

Group A

EXPERIMENTAL

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 B

EXPERIMENTAL

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.

Interventions

IV nalbuphine 0.1 mg/kg with induction of anesthesia. DRUG

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

Also known as: nalufin

Group A

IV nalbuphine 0.1 mg/kg at the end of surgery. DRUG

Group B: 40 patients will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.

Also known as: nalufin

Group B

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (5)

• Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. doi: 10.1213/01.ane.0000250914.91881.a8.

  PMID: 17179249 BACKGROUND

• Aono J, Ueda W, Mamiya K, Takimoto E, Manabe M. Greater incidence of delirium during recovery from sevoflurane anesthesia in preschool boys. Anesthesiology. 1997 Dec;87(6):1298-300. doi: 10.1097/00000542-199712000-00006.

  PMID: 9416712 BACKGROUND

• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

  PMID: 15114210 BACKGROUND

• Taddio A, Nulman I, Koren BS, Stevens B, Koren G. A revised measure of acute pain in infants. J Pain Symptom Manage. 1995 Aug;10(6):456-63. doi: 10.1016/0885-3924(95)00058-7.

  PMID: 7561228 BACKGROUND

• Chen JY, Jia JE, Liu TJ, Qin MJ, Li WX. Comparison of the effects of dexmedetomidine, ketamine, and placebo on emergence agitation after strabismus surgery in children. Can J Anaesth. 2013 Apr;60(4):385-92. doi: 10.1007/s12630-013-9886-x. Epub 2013 Jan 24.

  PMID: 23344921 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Nalbuphine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Hamdy Abbas, Professor

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.M.B.CH& Resident Doctor

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 19, 2018
• Study Start: July 31, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 1, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

EG (1)