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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT05124067

Collaborator

(none)

Enrollment

Location

Arms

4.5

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting Post Operative Pain Emergence Delirium	Drug: Dexamethasone Drug: Ondansetron Drug: Dexmedetomidine Drug: normal Saline	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 27, 2021

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Mar 12, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Number of participants who will develop postoperative nausea and vomiting and rate of development [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 Outcome Measures

Postoperative pain [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
Emergence delirium [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 Outcome Measures

Total granisetron dose given [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).
Number of participants with the following side effects [24 hours]
Number of participants that will develop bradycardia, hypotension or high blood glucose

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sharurah Armed Forces Hospital	Sharurah	Najran	Saudi Arabia	00000

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: AHMED A SHAMA, MD, LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE
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