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NCT Number: NCT05124067

Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Confusion Delirium Emergence Delirium Mental Disorders Nausea Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sharurah Armed Forces Hospital

Sharurah, Najran Region, 00000, Saudi Arabia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients 6-12 years.
  • Pediatric patients (ASA physical status I, II).
  • Scheduled for dental rehabilitation surgery

Exclusion criteria

  • Parental refusal
  • Allergy or contraindication to studied medication or anaesthetic agents.
  • Children with known gastroesophageal reflux disease.
  • Intake of antiemetic medication within 24 hours before surgery.
  • Past history or family history of previous postoperative nausea and vomiting.

Treatment and study plan

Dexamethasone

Drug

patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)

Other names: Dexamethasone Group

ondansetron

Drug

patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)

Other names: Ondansetron Group

Dexmedetomidine

Drug

Patients will receive dexmedetomidine (0.3 μg/kg)

Other names: Dexmedetomidine Group

normal saline

Drug

patients will receive normal saline.

Other names: Control Group

Primary outcomes

  1. Number of participants who will develop postoperative nausea and vomiting and rate of development

    Time frame: 24 hours

    Postoperative vomiting will be recorded by a nurse who will be blinded to study conditions. It will be treated if vomiting occurred more than twice in 2 minutes with granisetron (0.1mg/kg and repeated if necessary but not in less than 12 hours).

Secondary outcomes

  1. Postoperative pain

    Time frame: 24 hours

    Postoperative pain will be assessed at 1st, 2nd, 4th, 8th, 12th, 16th and 24th hrs. Postoperative by using the Pediatric Objective Pain Scale, where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia

  2. Emergence delirium

    Time frame: 15 minutes

    Emergence delirium using the pediatric anesthesia emergence delirium (PAED) scale at four-time points: T0: after extubation; T1: 5 min after extubation; T2: 10 min after extubation; T3: 15 min extubation.

    The PAED scale contains five items: eye contact, the purposefulness of actions, awareness of surroundings, restlessness and consolability. Each item will be scored into five grades (0-4) according to a degree, giving a maximum total of 20 points. Patients with severe agitation defined as a PAED score ≥ 10 will be treated with intravenous propofol (1 mg/kg)

Other outcomes

  1. Total granisetron dose given

    Time frame: 24 hours

    If vomiting occurred more than twice in 2 minutes will be treated with granisetron (0.1mg/kg and repeated if necessary but not in less than 12 hours).

  2. Number of participants with the following side effects

    Time frame: 24 hours

    Number of participants that will develop bradycardia, hypotension or high blood glucose

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effect Of Dexmedetomidine, Dexamethasone And Ondansetron On Postoperative Nausea And Vomiting In Children Undergoing Dental Rehabilitation

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2021
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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