Ingrid Liodden1, Leiv Sandvik2, Berit Taraldsen Valeberg3, Einar Borud1, Arne Johan Norheim1. 1. NAFKAM, Institute of Community Medicine, UiT the Arctic University of Norway, Tromsø, Norway. 2. Faculty of Odontology, University of Oslo, Oslo, Norway. 3. Faculty of Health Service, Oslo and Akershus College University of Applied Science, Oslo, Norway.
Abstract
OBJECTIVES: To investigate the effect of a standardised acupuncture on nausea and vomiting in children after tonsillectomy with or without adenoidectomy when possible placebo effects were precluded. METHODS: A pragmatic, multicentre, double-blinded, randomised controlled trial. The study was conducted over 10 months in 2012-2013 at three ambulatory clinics. Two hundred and eighty-two children, age 1-11 years, American Society of Anesthesiologists grade ≤II, were included. To equalise expectancy effects, all parents were told that their child would receive acupuncture. However, children were randomly allocated to perioperative bilateral needling acupuncture at PC6, depth 7 mm, mean time 17 min (SD 5-45) during anaesthesia plus usual care, or to usual care only. The regional ethics committee approved this approach. Primary endpoints were nausea and vomiting 24 h postoperatively. RESULTS: This study did not demonstrate any effect of acupuncture (95% CI) compared with standard care. The overall vomiting in the acupuncture and usual-care groups was 44.2% and 47.9%, respectively. Nausea was experienced by 31.7% in the acupuncture group and by 32.6% in the usual-care group. The test power was acceptable for comparisons of vomiting. CONCLUSIONS: The findings suggest that when controlling for possible placebo effects standardised PC6 acupuncture needling during anaesthesia without further stimulation of PC6 is not effective in reducing nausea and vomiting in children after tonsillectomy with or without adenoidectomy. Future studies should investigate acupuncture treatment which balances adequate dose and technique and a feasible, child-friendly acupuncture treatment. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01729052. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVES: To investigate the effect of a standardised acupuncture on nausea and vomiting in children after tonsillectomy with or without adenoidectomy when possible placebo effects were precluded. METHODS: A pragmatic, multicentre, double-blinded, randomised controlled trial. The study was conducted over 10 months in 2012-2013 at three ambulatory clinics. Two hundred and eighty-two children, age 1-11 years, American Society of Anesthesiologists grade ≤II, were included. To equalise expectancy effects, all parents were told that their child would receive acupuncture. However, children were randomly allocated to perioperative bilateral needling acupuncture at PC6, depth 7 mm, mean time 17 min (SD 5-45) during anaesthesia plus usual care, or to usual care only. The regional ethics committee approved this approach. Primary endpoints were nausea and vomiting 24 h postoperatively. RESULTS: This study did not demonstrate any effect of acupuncture (95% CI) compared with standard care. The overall vomiting in the acupuncture and usual-care groups was 44.2% and 47.9%, respectively. Nausea was experienced by 31.7% in the acupuncture group and by 32.6% in the usual-care group. The test power was acceptable for comparisons of vomiting. CONCLUSIONS: The findings suggest that when controlling for possible placebo effects standardised PC6 acupuncture needling during anaesthesia without further stimulation of PC6 is not effective in reducing nausea and vomiting in children after tonsillectomy with or without adenoidectomy. Future studies should investigate acupuncture treatment which balances adequate dose and technique and a feasible, child-friendly acupuncture treatment. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT01729052. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: E Anne Lown; Anu Banerjee; Eric Vittinghoff; Christopher C Dvorak; Wendy Hartogensis; Alexis Melton; Christina Mangurian; Hiroe Hu; Deborah Shear; Robyn Adcock; Michael Morgan; Carla Golden; Frederick M Hecht Journal: Glob Adv Health Med Date: 2019-08-14