Effect of Intravenous Nalbuphine on Emergence Agitation
Condition: Postoperative Complications
MeSH terms: Emergence Delirium; Postoperative Complications
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): IV nalbuphine 0.1 mg/kg with induction of anesthesia.; IV nalbuphine 0.1 mg/kg at the end of surgery.
Intervention type(s): Drug; Drug
Intervention description(s): Group A: 40 patients will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia.
.; Group B: 40 patients will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.
Other intervention name(s): nalufin; nalufin
Intervention MeSH terms: Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention