Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Postoperative Complications
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Double (Participant, 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 receivedPrimary Purpose: Prevention

Participation Requirements

Age
Between 3 years and 8 years
Gender
Both males and females

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...

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 sevo?urane 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 ?-receptor agonist ?-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.

Tracking Information

NCT #
NCT03470077
Collaborators
Not Provided
Investigators
Study Director: Hamdy Abbas, Professor Assiut University