Postoperative Nausea and VomitingPhase 1NCT05124067
Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children
A Phase 1 study testing Dexamethasone, Ondansetron and Dexmedetomidine in people with Postoperative Nausea and Vomiting and Post Operative Pain, run by Tanta University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting, Post Operative Pain, Emergence Delirium
- What is being tested?
- Dexamethasone, Ondansetron and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 27 Oct 2021to 12 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients 6-12 years.
- Pediatric patients (ASA physical status I, II).
- Scheduled for dental rehabilitation surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Sharurah Armed Forces Hospital
Sharurah, Najran Region, 00000
About this study
Official title: 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.
Read the 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
- Being tested
- Dexamethasone, Ondansetron, Dexmedetomidine, normal Saline
- Keywords
- dexmedetomidine, nausea and vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative, Emergence Delirium, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexamethasone Group
patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg)
OndansetronDrug
Also called Ondansetron Group
patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg)
DexmedetomidineDrug
Also called Dexmedetomidine Group
Patients will receive dexmedetomidine (0.3 μg/kg)
normal SalineDrug
Also called Control Group
patients will receive normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Group A (DEXA) | Experimental | patients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg) Receives: Drug: Dexamethasone |
| Group B (ONDAN) | Experimental | patients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg) Receives: Drug: Ondansetron |
| Group C (DEXMED) | Experimental | Patients will receive dexmedetomidine (0.3 μg/kg) Receives: Drug: Dexmedetomidine |
| Group D (CONTROL) | Placebo comparator | patients will receive normal saline Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Secondary outcomes (2)
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
Measured: 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)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start27 Oct 2021
- Primary completion30 Jan 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED ABDELAZIZ SHAMA, Tanta University
- Investigators
- AHMED A SHAMA, MD, Principal investigator, LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINESHERIF K ARAFA, MD, Study chair, Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINEAMIR A EL-SAYED, MD, Study chair, Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124067
- Sponsor's protocol ID
- IRC13407/10/21
- Status last verified
- Apr 2022
- First submitted
- 5 Nov 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Dexmedetomidine, Dexamethasone And Ondansetron On Postoperative Nausea And Vomiting In Children Undergoing Dental Rehabilitation
- ClinicalTrials.gov ID
- NCT05124067
- Acronym / sponsor ID
- IRC13407/10/21
- Keywords
- dexmedetomidine, nausea and vomiting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (DEXA) | Experimental | Drug: Dexamethasonepatients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg) |
| Group B (ONDAN) | Experimental | Drug: Ondansetronpatients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg) |
| Group C (DEXMED) | Experimental | Drug: DexmedetomidinePatients will receive dexmedetomidine (0.3 μg/kg) |
| Group D (CONTROL) | Placebo comparator | Drug: normal Salinepatients will receive normal saline |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients 6-12 years.
- Pediatric patients (ASA physical status I, II).
- Scheduled for dental rehabilitation surgery
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Dexamethasone Grouppatients will receive dexamethasone (0.15 mg/kg IV; maximum 5 mg) | Drug | Group A (DEXA) |
| OndansetronAlso: Ondansetron Grouppatients will receive ondansetron (0.05 mg/kg IV; maximum 4 mg) | Drug | Group B (ONDAN) |
| DexmedetomidineAlso: Dexmedetomidine GroupPatients will receive dexmedetomidine (0.3 μg/kg) | Drug | Group C (DEXMED) |
| normal SalineAlso: Control Grouppatients will receive normal saline. | Drug | Group D (CONTROL) |
Primary outcome
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).
2 secondary outcomes
Postoperative pain
Time frame: 24 hours
Emergence delirium
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED A SHAMA, MD principal investigator
LECTURER OF ANESTHESIA AND SURGICAL ICU, TANTA UNIVERSITY, FACULTY OF MEDICINE
SHERIF K ARAFA, MD study chair
Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE
AMIR A EL-SAYED, MD study chair
Assistant professor of Anesthesia &ICU,Kafr El sheikh University, FACULTY OF MEDICINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone, Ondansetron and Dexmedetomidine in people with Postoperative Nausea and Vomiting and Post Operative Pain, run by Tanta University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who will develop postoperative nausea and vomiting and rate of development (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.