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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124067
• Other study ID #: IRC13407/10/21
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2021
• Est. completion date: March 12, 2022

Study information

• Verified date: April 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 12, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Nausea
• Pain, Postoperative
• Post Operative Pain
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexamethasone
patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)
• Ondansetron
patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)
• Dexmedetomidine
Patients will receive dexmedetomidine (0.3 µg/kg)
• normal Saline
patients will receive normal saline.

Locations

Country	Name	City	State
Saudi Arabia	Sharurah Armed Forces Hospital	Sharurah	Najran

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number of participants with the following side effects	Number of participants that will develop bradycardia, hypotension or high blood glucose	24 hours
Primary	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	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
Secondary	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