Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children
Condition: Postoperative Nausea and Vomiting; Post Operative Pain; Emergence Delirium
MeSH terms: Emergence Delirium; Nausea; Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      this study will aim to evaluate the effects of dexmedetomidine, dexamethasone and Ondansetron
      on the prevention of postoperative nausea and vomiting in children undergoing dental
      rehabilitation surgery.
    

Detailed description: 
      Postoperative nausea and vomiting (PONV) is one of the most common and unpleasant
      postoperative complications, which is a major concern in surgical patients. PONV affects
      about 20-40% of surgical patients, with certain high-risk patients experiencing rates of up
      to 80%.

      It has a high incidence in children, especially for tonsillectomy and dental surgery. PONV
      could lead to several adverse consequences, including dehydration, electrolyte imbalance, and
      wound dehiscence. it has also been reported PONV is associated with delayed hospital
      discharge, unplanned hospital admission, and increased financial costs required for patient
      care.

      Several anti-emetic drugs have been described for the prophylactic control of PONV.
      Dexamethasone is common practice in surgery, as part of a multimodal pain and antiemetic
      strategy.

      Ondansetron is a selective 5-HT3 receptor antagonist that exhibits an anti-emetic action by
      antagonizing vomiting signals in the afferent pathway from the stomach or small intestine and
      solitary tract nucleus and is effective at preventing PONV, however, the high cost of this
      drug has prevented it from being widely used.

      Dexmedetomidine is a highly selective α2-adrenoreceptor agonist which has been widely used in
      clinical practice and has been explored extensively in the pediatric population due to its
      beneficial effects on perioperative morbidities. In the past few years, many studies in
      paediatrics have been published showing that dexmedetomidine lowered postoperative pain
      scores and opioid consumption, decreased the incidence of emergence agitation (EA), and
      improved the quality of recovery in pediatric patients undergoing different surgical
      procedures. In addition, a small selection of studies reported that dexmedetomidine could
      lower the incidence of nausea or vomiting after surgery and during the use of
      patient-controlled analgesia (PCA) in paediatrics. However, the effect of dexmedetomidine on
      PONV remains poorly understood.

      In this study, investigators will evaluate the effect of dexmedetomidine on preventing
      postoperative nausea and vomiting in children in comparison with dexamethasone and
      ondansetron
    

Intervention name(s): Dexamethasone; Ondansetron; Dexmedetomidine; normal Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg); patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg); Patients will receive dexmedetomidine (0.3 μg/kg); patients will receive normal saline.
Other intervention name(s): Dexamethasone Group; Ondansetron Group; Dexmedetomidine Group; Control Group
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexmedetomidine; Ondansetron; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dexmedetomidine; nausea and vomiting