Postoperative VomitingPhase 2/3NCT00965367
Postoperative Nausea and Vomiting and Acupuncture/Acupressure
A Phase 2/3 study testing Acustimulation in people with Postoperative Vomiting and Nausea, run by National Research Centre of Complementary and Alternative Medicine, Norway at 1 site in Norway.
Trial summary
Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Postoperative Vomiting, Nausea
- What is being tested?
- Acustimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteNorway
- Study dates
- May 2008to Nov 2008
- Phase
- Phase 2/3
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled for tonsillectomy and/or adenoidectomy
- Informed consent from the parents/guardians
Who cannot join
- ASA grade greater than or equal to III (patients with severe systemic disease)
- Rash or local infection over an acupuncture point
- Emesis during the previous 24 hours
- Use of medication with antiemetic effect and/or other antiemetic therapy within the 24 hours before surgery
- Gastric or intestinal diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Acustimulation Attenuate Postoperative Nausea and Vomiting in Children Who Have Undergone Tonsillectomy/Adenoidectomy?
Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal.
Consequently, the investigators will investigate if acupuncture and acupressure can be implemented as a supplementary to the ordinary treatment in children undergoing surgery for tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion decisions are conducted after the "intention-to-treat" principle. 126 patients are included, divided into two groups:
Read more
- Treatment Group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening
- Control Group - standard treatment
The primarily endpoints in this study are nausea, retching and vomiting. The effect of acupuncture/acupressure will be studied with regard to any association with possible factors of predisposition to PONV, as well as with other factors registered during the study. Adverse effects from the acupuncture site and wristband will be registered.
- Conditions
- Postoperative Vomiting, Nausea
- Being tested
- Acustimulation
- Keywords
- POV tonsillectomy adenoidectomy acupuncture acupressure child, Effectiveness of acupuncture on
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcustimulationDevice
Acupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Acustimulation | Experimental | Not described Receives: Device: Acustimulation |
| Standard treatment group | No intervention | Not described Receives: Device: Acustimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
Measured: 24 hours
Secondary outcomes (1)
The effect of the intervention will be studied with regard to any association with possible factors of predisposition to PONV. Adverse effects will also be registered.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startMay 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative VomitingStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre of Complementary and Alternative Medicine, Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Lovisenberg Diaconale Hospital
- Investigators
- Arne Johan Norheim, MD Doctor phD, Principal investigator, National Research Centre of Complementary and Alternative Medicine, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965367
- Sponsor's protocol ID
- 125/2007
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 25 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Acustimulation Attenuate Postoperative Nausea and Vomiting in Children Who Have Undergone Tonsillectomy/Adenoidectomy?
- ClinicalTrials.gov ID
- NCT00965367
- Acronym / sponsor ID
- 125/2007
- Conditions
- Postoperative Vomiting, Nausea
- Keywords
- POV tonsillectomy adenoidectomy acupuncture acupressure child, Effectiveness of acupuncture on
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- National Research Centre of Complementary and Alternative Medicine, NorwayUniversity, hospital or other
- Collaborators
- Lovisenberg Diaconale Hospital
- Study start
- May 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Aug 2009 (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.
Postoperative nausea and vomiting (PONV) remain a significant challenge in the investigators practice. However, pharmaceutical prophylaxis can imply unpleasant adverse effects. It would therefore be appropriate to consider the use of non-pharmacological methods in preventing PONV. Acupuncture and acupressure are reported to be effective preventive treatment for PONV, and the adverse effects are minimal.
Consequently, the investigators will investigate if acupuncture and acupressure can be implemented as a supplementary to the ordinary treatment in children undergoing surgery for tonsillectomy and/or adenoidectomy. The study will also focus on the feasibility for acupuncture and acupressure in the operation theatre. The study and inclusion/exclusion decisions are conducted after the "intention-to-treat" principle. 126 patients are included, divided into two groups:
- Treatment Group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening
- Control Group - standard treatment
The primarily endpoints in this study are nausea, retching and vomiting. The effect of acupuncture/acupressure will be studied with regard to any association with possible factors of predisposition to PONV, as well as with other factors registered during the study. Adverse effects from the acupuncture site and wristband will be registered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acustimulation | Experimental | Device: Acustimulation |
| Standard treatment group | No intervention | Device: Acustimulation |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children scheduled for tonsillectomy and/or adenoidectomy
- Informed consent from the parents/guardians
Key exclusion criteria (5 listed)
- ASA grade greater than or equal to III (patients with severe systemic disease)
- Rash or local infection over an acupuncture point
- Emesis during the previous 24 hours
- Use of medication with antiemetic effect and/or other antiemetic therapy within the 24 hours before surgery
- Gastric or intestinal diseases
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 |
|---|---|---|
| AcustimulationAcupressure in P6 bilaterally given after induction of anaesthesia for 20 minutes, followed by acupressure wrist bands applied on the same acupoints for 24 hours. | Device | Acustimulation, Standard treatment group |
Primary outcome
Postoperative nausea and vomiting
Time frame: 24 hours
1 secondary outcome
The effect of the intervention will be studied with regard to any association with possible factors of predisposition to PONV. Adverse effects will also be registered.
Time frame: 24 hours
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 25 Aug 2009.
Related trials for Postoperative Vomiting
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
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.
Arne Johan Norheim, MD Doctor phD principal investigator
National Research Centre of Complementary and Alternative Medicine, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acustimulation in people with Postoperative Vomiting and Nausea, run by National Research Centre of Complementary and Alternative Medicine, Norway at 1 site in Norway.
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 2 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 25 Aug 2009. 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 Norway. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Postoperative nausea and vomiting (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 25 Aug 2009.