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.: PACTR201711002816160 Date of Approval: 28/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Glosspharyngeal nerve block after adenotensollectomy
Official scientific title Effect of glosspharyngeal nerve block by bupivacaine alone vs dexmedetomidine & bupivacaine vs bupivacaine-pethidine on postoperative pain and PONV after pediatric adeno-tonsillectomy
Brief summary describing the background and objectives of the trial Postoperative pain is the principal cause of morbidity after tonsillectomy. This pain can affect the patient¿s nutrition, ability to return to work or school, discharge from the hospital, and overall satisfaction with the procedure. Tonsillectomy produces severe pain on the first postoperative day (1). Several techniques have been described for the alleviation of this pain, including the use of opioids (2), steroids (3), and non-steroidal anti-inflammatory drugs (2,4), as well as local anesthetic sprays (5) and infiltration with local anesthetics around the tonsillar bedThere is some controversy regarding the efficacy of glossopharyngeal nerve block (GNB) for the control of immediate posttonsillectomy pain. Some authors have reported that GNB or modified peritonsillar infiltration with local anesthetic are effective for pain associated with tonsillectomy (11¿15). Other reports indicated that GNB with 0.5% bupivacaine or ropivacaine was ineffective for the reduction of early post-tonsillectomy pain in adult and pediatric patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Post-operative nausea and vomiting and pain after pediatric adeno-tonsillectomy,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 05/08/2017
Actual trial start date
Anticipated date of last follow up 01/07/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet 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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group bupivacaine group 10 mL of solution (1mg\ kg bupivacaine 0.5%) at the end of surgery before extubation After careful aspiration, 10 mL of solution (1mg\ kg bupivacaine 0.5%) will be prepared and injected slowly (5ml \each side). 40 Active-Treatment of Control Group
Experimental Group pethidine group 10 mL of solution (1mg\ kg bupivacaine 0.5% and pethidine 1 mg \kg) at the end of surgery before extubation After careful aspiration, 10 mL of solution (1mg\ kg bupivacaine 0.5% and pethidine 1 mg \kg) will be prepared and injected slowly (5ml \each side). 40 Active-Treatment of Control Group
Experimental Group dexmetomidine group 10 mL of solution (1mg\ kg bupivacaine 0.5% and dexmetomidine 1 ug \kg) at the end of surgery before extubation After careful aspiration, 3 mL of solution (1mg\ kg bupivacaine 0.5% and dexmetomidine 1 ug \kg) will be prepared and injected slowly (5ml \each side). 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
120 childern of either sex, ASA I &II, age 3-10 years, scheduled to undergoing undergo adeno-tonsillectomy Diabetes, cardiac anomalies, liver or kidney disease, hypersensitivity to local anesthetics, chronic pain, regular analgesic use within 1 wk of surgery, peritonsillar abscess or swallowing disorder 3 Year(s) 10 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 26/07/2017 research ethics committee, quality assurance unit
Ethics Committee Address
Street address City Postal code Country
1, algeish st, tant,algharbia governate, egypt tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain at rest and swallowing 30 minutes after surgery, 2hr, 4, 6, 8, 12, 24hrs postoperatively
Secondary Outcome postoperative nausea and vomiting from extubation till 24 hrs p[ostoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital 1, algeish st, tant,algharbia governate, egypt tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital 1, algeish st, tanta,algharbia governate, egypt tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Ali Ahmed Abogeba 3 elwahda el arabia street, mehalla elkobra tanta 31961 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amany omara amanyfaheem2011@yahoo.com 01008372249 22 emar elhoda 1, el estad street. tanta
City Postal code Country Position/Affiliation
tanta 31511 Egypt
Role Name Email Phone Street address
Public Enquiries nada omara Dr.nada.emera@gmail.com 01118342012 12 nor l din st, tanta,algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt
Role Name Email Phone Street address
Scientific Enquiries sohair soliman sohairsoliman@hotmail.com 01155338808 moheb st, tanta,algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31511 Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information