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

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

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.

Study Overview

• Status: Completed
• Conditions: Emergence Delirium; Postoperative Nausea and Vomiting; Post Operative Pain
• Intervention / Treatment: Drug: Dexamethasone; Drug: Ondansetron; Drug: Dexmedetomidine; Drug: normal Saline

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

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• Saudi Arabia
  • Najran
    • Sharurah, Najran, Saudi Arabia, 00000
      • Sharurah Armed Forces Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A (DEXA); patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)	Drug: Dexamethasone; patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg); Other Names: Dexamethasone Group
EXPERIMENTAL: Group B (ONDAN); patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)	Drug: Ondansetron; patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg); Other Names: Ondansetron Group
EXPERIMENTAL: Group C (DEXMED); Patients will receive dexmedetomidine (0.3 μg/kg)	Drug: Dexmedetomidine; Patients will receive dexmedetomidine (0.3 μg/kg); Other Names: Dexmedetomidine Group
PLACEBO_COMPARATOR: Group D (CONTROL); patients will receive normal saline	Drug: normal Saline; patients will receive normal saline.; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who will develop postoperative nausea and vomiting and rate of development	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).	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	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	24 hours
Emergence delirium	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)	15 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total granisetron dose given	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).	24 hours
Number of participants with the following side effects	Number of participants that will develop bradycardia, hypotension or high blood glucose	24 hours

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Chair: SHERIF K ARAFA, MD, Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE; Study Chair: AMIR A EL-SAYED, MD, Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2021
• Primary Completion (ACTUAL): January 30, 2022
• Study Completion (ACTUAL): March 12, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (ACTUAL): November 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 3, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: dexmedetomidine; nausea and vomiting
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Signs and Symptoms, Digestive; Delirium; Pain, Postoperative; Nausea; Vomiting; Emergence Delirium; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Hypnotics and Sedatives; Anti-Anxiety Agents; Antipruritics; Dexamethasone; Dexamethasone acetate; BB 1101; Dexmedetomidine; Ondansetron
• Other Study ID Numbers: IRC13407/10/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes