Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201806003339337 Date of Approval: 21/04/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Acupuncture for pain control after adenotonsillectomy
Official scientific title Assessment of acupuncture efficacy in postoperative pain control in children undergoing adenotonsillectomy
Brief summary describing the background and objectives of the trial Pain is a highly prevalent and costly health problem which can occur at any age.Complementary and alternative medicine (CAM)therapies, especially acupuncture, offer additional options in pain management. These CAM options tend to be cheaper, less invasive, and of lower risk than the second and third line conventional treatments of strong narcotics and invasive surgical procedures. Acupuncture can reduce the severity of pain, allowing for reduced doses of medications.Auricular therapy is one form of acupuncture and a well-recognized element of traditional Chinese medicine.Studies using auricular therapy have shown promising effects in the pain management of several conditions, including dysmenorrhea,postoperative pain, hip fracture, low back pain, and bone marrow aspiration.Studies in auricular therapy for pain management have increased since the 1980s. In order to gather and evaluate up-to-date evidence of auricular therapy efficacy for pain management, this study will be conducted to evaluate whether using acupuncture can reduce the need for pharmaceutical analgesics to control postoperative pain of adeno-tonsillectomy in children age group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,Paediatrics,postoperative pain management
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2018
Actual trial start date
Anticipated date of last follow up 01/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 58
Actual target sample size (number of participants) 58
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a randomisation table from a statistics book Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group acupuncture group 4 different acupuncture points till end of surgery Anesthesia will be induced by inhalational sevofluorane.The patients will be orotracheally intubated after intravenous administration of 2 to 4 mg/kg of Propofol, and 1mcg/kg of fentanyl.ACUPUNCTURE: Will be performed in :LI4, KI6,P6 and HT7 points 29
Control Group control group till the end of surgery Anesthesia will be induced by inhalational sevofluorane.The patients will be orotracheally intubated after intravenous administration of 2 to 4 mg/kg of Propofol, and 1mcg/kg of fentanyl. acupuncture will not be done 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Children undergoing adeno-tonsillectomy. 2) Males and females 3) age from 3¿12 years 1) Skin lesions near acupuncture sites. 2) Psychiatric disorders. 3) Coagulopathy. 4) Intake of medications possibly affecting postoperative pain. 3 Year(s) 12 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/09/2017 suez canal university,faculty of medicine research ethics committee
Ethics Committee Address
Street address City Postal code Country
kilo 4.5,the ring road ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative first request of analgesia after recovery from anesthesia
Secondary Outcome blood pressure baseline Post-Induction every 5 mins till end of surgery Post-Extubation postoperative every 30 mins for 2hours
Secondary Outcome heart rate baseline Post-Induction every 5 mins till end of surgery Post-Extubation postoperative every 30 mins for 2hours
Secondary Outcome O2 saturation % baseline Post-Induction every 5 mins till end of surgery Post-Extubation postoperative every 30 mins for 2hours
Secondary Outcome pain scores according to facial analogue scores postoperative every 30 mins for 2 hours
Secondary Outcome postoperative analgesic consumption 1st 2hours after surgery
Secondary Outcome nausea and/or vomiting postoperative for 2 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road ,kilo 4.5 ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor anesthesia dapartemnt,faculty of medicine,suez canal university the ring road ,kilo 4.5 ismailia 41522 Egypt Charities/Societies/Foundation
Primary Sponsor suez canal university hospital the ring road ,kilo 4.5 ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Haddier Mahmoud Farouk Midan kilo 4.5 the ring road ismailia 41522 Egypt
mohamed elsayed ibrahim ard elgameiat ismailia 41522 Egypt
Hossam Mohamed Atef kilo 4.5 the ring road ismailia 41522 Egypt
Salah Abd El Fattah Mohamed kilo 4.5 the ring road ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haddier Midan dr.haddier.midan.89@gmail.com 002-01001592407 kilo 4.5 the ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt resident doctor
Role Name Email Phone Street address
Public Enquiries mohamed abuelnaga Mohamed_abuelnga@med.suez.edu.eg 002-01004150671 ard elgameiat
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries salah abdel fattah salahsenna@hotmail.com 002-01001573722 kilo 4.5 the ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt professor of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries Hossam Atef hosamatef375@yahoo.com 002-01097531369 kilo 4.5 the ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia and intensive care
REPORTING
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