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.: PACTR201306000541481 Date of Approval: 29/04/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of intravenous diclofenac on postoperative sore throat
Official scientific title Effects of intravenous diclofenac on postoperative sore throat in patients undergoing laparoscopic surgery at Aga Khan University Hospital, Nairobi: a randomized, double blind controlled trial
Brief summary describing the background and objectives of the trial Postoperative sore throat (POST) is the commonest complication after endotracheal intubation. the efficacy of intravenous non-steroidal anti-inflammatory drugs in alleviating postoperative sore throat has not been investigated. the objective of this trial is to evaluate the effect of intravenous diclofenac sodium on the occurence and severity of POST
Type of trial RCT
Acronym (If the trial has an acronym then please provide) POST
Disease(s) or condition(s) being studied Ear, Nose and Throat,Pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2011
Actual trial start date 01/01/2011
Anticipated date of last follow up 29/04/2011
Actual Last follow-up date 15/04/2011
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
Recruitment status Completed
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 created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intravenous diclofenac 75 mg once 30 minutes analgesic 21
Control Group Standard treatment 200 mls Normal saline 21 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult american society of anaesthesiologists (ASA) class 1 to 3 inpatients that would be intubated for laparoscopic surgery patient refusal; daycare patients; hypersensitivity to diclofenac; atopic patients; third trimester pregnancy; active stomach and/or duodenal ulcer or gastrointestinal bleeding; inflammatory intestinal disorders; severe heart insufficiency; severe liver insufficiency; severe renal insufficiency; severe active bleeding; use of oral or inhaled steroids; paediatric patients; psychologic disturbances; sore throat prior to intubation; coagulopathy 18 Year(s) 60 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 30/11/2010 Aga Khan University Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3rd parklands avenue off Limuru road Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of intravenous diclofenac on prevention of occurence of POST two hours postoperatively six hours postoperatively eighteen hours postoperatively
Secondary Outcome Severity of postoperative sore throat on numerical rating scale two hours postoperatively six hours postoperatively eighteen hours postoperatively eighteen hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Aga Khan University Hospital, 3rd parklands avenue off Limuru Road Nairobi 00100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
university research council 3rd paklands avenue off Limuru road Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aga Khan University research committee 3rd parklands avenue off Limuru Road Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Aga Khan University Hospital nairobi 3rd parklands avenue off Limuru Road Nairobi 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Pauline Thang'a wanguithanga@gmail.com +254 20 3662158 3rd parklands avenue off Limuru road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Instructor
Role Name Email Phone Street address
Public Enquiries kamanda ciru kamanda.ciru@aku.edu +254 20 3662148 3rd parklands avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Aga Khan University research support unit
Role Name Email Phone Street address
Scientific Enquiries vitalis mung'ayi vitalis.mung'ayi@aku.edu + 254 20 3662158 3rd parklands avenue
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Aga Khan University
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