VomitingPhase 4NCT02387918
Prevention of POV After Paediatric Tonsillectomy
A Phase 4 study testing Dexamethasone and Acupuncture in people with Vomiting, run by Assiut University at 1 site in Egypt.
Trial summary
Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Vomiting
- What is being tested?
- Dexamethasone and Acupuncture
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Oct 2015
- Phase
- Phase 4
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 2-8 y.
- children ASA 1-2
- tonsillectomy with or without adenoidectomy
Who cannot join
- American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)
- intravenous induction
- contraindication to steroids
- Rash or local infection over an acupuncture point
- administration of steroids in the 24 hours before the surgery
- Use of medication with antiemetic effect within the 24 hours before surgery
- Gastric or intestinal diseases
- refusal of parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vomiting After Tonsillectomy in Children: A Comparison of Dexamethasone and Acupuncture
Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Current medications for POV have limited efficacy and may even be associated with potential side-effects. Non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for POV.
Read the detailed description
Postoperative vomiting (POV) is one of the most common complication in children undergoing tonsillectomy. Its incidence is between 62% and 73% when no prophylactic antiemetic is given. Because of Limited efficacy and side effects with antiemetics, many alternative treatment had been used. Acupuncture is simple, inexpensive, and noninvasive with minimal side effects. The objective of this study is to compare two prophylactic antiemetic treatments :
- Dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia
- Acupuncture treatment (immediately after induction of anaesthesia and for approximately 20 minutes)
- Conditions
- Vomiting
- Being tested
- Dexamethasone, Acupuncture
- Keywords
- Tonsillectomy, postoperative vomiting (POV), Dexamethasone, Acupuncture
- Medical subject headings
- Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.
AcupunctureDevice
Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia. Receives: Drug: Dexamethasone |
| Acupuncture | Active comparator | Acupuncture at point Neiguan (Pericardium-6) bilaterally and at point CV13 (Shang Wen) with acupuncture needles (0.25x25 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed after 20 minutes Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POV after tonsillectomy with or without adenoidectomy
by 3 point ordinal scale
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham Ibrahim, Lecturer, Principal investigator, health,Higher education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387918
- Sponsor's protocol ID
- SM2015
- Status last verified
- Jan 2016
- First submitted
- 27 Feb 2015
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vomiting After Tonsillectomy in Children: A Comparison of Dexamethasone and Acupuncture
- ClinicalTrials.gov ID
- NCT02387918
- Acronym / sponsor ID
- SM2015
- Conditions
- Vomiting
- Keywords
- Tonsillectomy, postoperative vomiting (POV), Dexamethasone, Acupuncture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 Mar 2015 (estimated)
- 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.
Tonsillectomy is one of the most frequently performed surgical procedures in children. It remains associated with a high morbidity related to postoperative vomiting (POV), pain, risk of bleeding, and dehydration due to impaired oral intake. Current medications for POV have limited efficacy and may even be associated with potential side-effects. Non-pharmacological techniques such as acupuncture has been investigated as alternatives to antiemetics and as additional treatment modalities for POV.
Detailed description
Postoperative vomiting (POV) is one of the most common complication in children undergoing tonsillectomy. Its incidence is between 62% and 73% when no prophylactic antiemetic is given. Because of Limited efficacy and side effects with antiemetics, many alternative treatment had been used. Acupuncture is simple, inexpensive, and noninvasive with minimal side effects. The objective of this study is to compare two prophylactic antiemetic treatments :
- Dexamethasone (0.15 mg/kg) immediately after induction of anaesthesia
- Acupuncture treatment (immediately after induction of anaesthesia and for approximately 20 minutes)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasonePatients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia. |
| Acupuncture | Active comparator | Device: AcupunctureAcupuncture at point Neiguan (Pericardium-6) bilaterally and at point CV13 (Shang Wen) with acupuncture needles (0.25x25 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed after 20 minutes |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 2-8 y.
- children ASA 1-2
- tonsillectomy with or without adenoidectomy
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists grade greater than or equal to III (patient with severe systemic disease)
- intravenous induction
- contraindication to steroids
- Rash or local infection over an acupuncture point
- administration of steroids in the 24 hours before the surgery
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 |
|---|---|---|
| DexamethasonePatients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia. | Drug | Dexamethasone |
| AcupunctureAcupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes) | Device | Acupuncture |
Primary outcome
Incidence of POV after tonsillectomy with or without adenoidectomy
Time frame: 24 hours postoperatively
by 3 point ordinal scale
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 22 Jan 2016.
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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.
Seham Ibrahim, Lecturer principal investigator
health,Higher education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Acupuncture in people with Vomiting, run by Assiut University at 1 site in Egypt.
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 8 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 22 Jan 2016. 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 Egypt. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of POV after tonsillectomy with or without adenoidectomy (time frame: 24 hours postoperatively). 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 22 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.