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

Primary Purpose

Postoperative Nausea and Vomiting, Post Operative Pain, Emergence Delirium

Status
Completed
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Dexamethasone
Ondansetron
Dexmedetomidine
normal Saline
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring dexmedetomidine, nausea and vomiting

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sharurah Armed Forces Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group A (DEXA)

Group B (ONDAN)

Group C (DEXMED)

Group D (CONTROL)

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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)

Full Information

First Posted
November 5, 2021
Last Updated
April 3, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05124067
Brief Title
Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children
Official Title
Effect Of Dexmedetomidine, Dexamethasone And Ondansetron On Postoperative Nausea And Vomiting In Children Undergoing Dental Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
March 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Post Operative Pain, Emergence Delirium
Keywords
dexmedetomidine, nausea and vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (DEXA)
Arm Type
Experimental
Arm Description
patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)
Arm Title
Group B (ONDAN)
Arm Type
Experimental
Arm Description
patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)
Arm Title
Group C (DEXMED)
Arm Type
Experimental
Arm Description
Patients will receive dexmedetomidine (0.3 μg/kg)
Arm Title
Group D (CONTROL)
Arm Type
Placebo Comparator
Arm Description
patients will receive normal saline
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexamethasone Group
Intervention Description
patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Ondansetron Group
Intervention Description
patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine Group
Intervention Description
Patients will receive dexmedetomidine (0.3 μg/kg)
Intervention Type
Drug
Intervention Name(s)
normal Saline
Other Intervention Name(s)
Control Group
Intervention Description
patients will receive normal saline.
Primary Outcome Measure Information:
Title
Number of participants who will develop postoperative nausea and vomiting and rate of development
Description
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).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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
Time Frame
24 hours
Title
Emergence delirium
Description
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)
Time Frame
15 minutes
Other Pre-specified Outcome Measures:
Title
Total granisetron dose given
Description
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).
Time Frame
24 hours
Title
Number of participants with the following side effects
Description
Number of participants that will develop bradycardia, hypotension or high blood glucose
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED A SHAMA, MD
Organizational Affiliation
LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SHERIF K ARAFA, MD
Organizational Affiliation
Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
AMIR A EL-SAYED, MD
Organizational Affiliation
Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE
Official's Role
Study Chair
Facility Information:
Facility Name
Sharurah Armed Forces Hospital
City
Sharurah
State/Province
Najran
ZIP/Postal Code
00000
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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