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Effect of Intravenous Nalbuphine on Emergence Agitation

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03470077
Enrollment
80
Registered
2018-03-19
Start date
2019-07-31
Completion date
2020-12-01
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

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.

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.

Interventions

DRUGIV 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. .

DRUGIV 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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, 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

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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of Emergence Agitation in children undergoing repair of rupture globe under general anesthesiaat the first 30 minutes after surgerythe 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

MeasureTime frameDescription
The severity of Emergency Agitationat the first 30 minutes after surgery5- 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
postoperative vomitingfirst 48 hours after surgeryPostoperative 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.
Postoperative sedationfirst 48 hours after surgeryPostoperative 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).
Postoperative FLACC Pain Scorefirst 24 hours after surgeryFace, Legs, Activity, Cry, and Consolability (FLACC) pain score

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026