Effect of Intravenous Nalbuphine on Emergence Agitation

Postoperative Complications Clinical Trial

Official title:

Effect of Intravenous Nalbuphine on Emergence Agitation in Children Undergoing Repair of Rupture Globe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470077
• Other study ID #: postoperative EA in children
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergence Delirium
• Postoperative Complications

Intervention

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. .
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

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. — View Citation

Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. — View Citation

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. — View Citation

Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg. 2007 Jan;104(1):84-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.; Calm; Not calm, but could be easily calmed; Moderately agitated or restless; Combative, excited, disoriente	at the first 30 minutes after surgery
Secondary	The severity of Emergency Agitation	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	at the first 30 minutes after surgery
Secondary	postoperative vomiting	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.	first 48 hours after surgery
Secondary	Postoperative sedation	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).	first 48 hours after surgery
Secondary	Postoperative FLACC Pain Score	Face, Legs, Activity, Cry, and Consolability (FLACC) pain score	first 24 hours after surgery