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| Name | Class |
|---|---|
| Norwegian Foundation for Health and Rehabilitation | OTHER |
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Postoperative nausea and vomiting (PONV) remain a significant challenge in our practice. However, pharmaceutical prophylaxis is only partially effective and can imply unpleasant adverse effects. Accordingly, the use of non-pharmacological methods in preventing PONV is appropriate. Acupuncture is reported to reduce PONV and pain, and the adverse events are minimal.
The objective of this multicentre, double-blinded, randomized, controlled trial is to investigate whether acupuncture can be a supplementary to the ordinary treatment in children undergoing tonsillectomy and/or adenoidectomy. In addition, the non-specific effect of parental attitudes and expectations on the outcomes will be explored.
Two hundred and eighty patients will be included and randomized into two groups
The primary endpoints in the intervention study are nausea, retching, vomiting and pain during 24 hours postoperatively. The effect of acupuncture 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 events from acupuncture will be registered.
The objective of the self-report questionnaires is to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture and standard treatment | Experimental | Acupuncture at Neiguan (Pericardium-6) bilaterally with Seirin needles no 3 (0.20x15 mm) to a depth of approximately 7 mm will be performed on the children immediately after induction of anaesthesia and removed before they are fully awake. Standard treatment: general anaesthesia |
|
| Standard treatment | No Intervention | General anaesthesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative nausea Postoperative vomiting Postoperative pain | Within 24 hours postoperatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Parental attitudes Parental expectations | Within 24 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arne Johan Norheim, dr.phil. | NAFKAM, UiT | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29898710 | Derived | Liodden I, Pripp AH, Norheim AJ. Placebo by proxy expectations toward acupuncture change over time: a survey comparing parental expectations to acupuncture pre- and postoperatively. BMC Complement Altern Med. 2018 Jun 14;18(1):183. doi: 10.1186/s12906-018-2248-z. | |
| 26840420 | Derived | Liodden I, Sandvik L, Norheim AJ. Placebo by Proxy--the Influence of Parental Anxiety and Expectancy on Postoperative Morbidities in Children. Forsch Komplementmed. 2015;22(6):381-7. doi: 10.1159/000442565. Epub 2015 Dec 7. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 25870177 | Derived | Liodden I, Sandvik L, Valeberg BT, Borud E, Norheim AJ. Acupuncture versus usual care for postoperative nausea and vomiting in children after tonsillectomy/adenoidectomy: a pragmatic, multicentre, double-blinded, randomised trial. Acupunct Med. 2015 Jun;33(3):196-203. doi: 10.1136/acupmed-2014-010738. Epub 2015 Apr 13. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |