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.: PACTR201410000854305 Date of Approval: 13/07/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF INTRAOPERATIVE LOW DOSE KETAMINE ON COST OF POSTOPERATIVE PAIN MANAGEMENT AFTER MAJOR SURGERY: A RANDOMIZED CONTROL TRIAL
Official scientific title EFFECTS OF INTRAOPERATIVE LOW DOSE KETAMINE ON COST OF POSTOPERATIVE PAIN MANAGEMENT AFTER MAJOR SURGERY: A RANDOMIZED CONTROL TRIAL
Brief summary describing the background and objectives of the trial Developing countries face constraints in meeting healthcare requirements. This is complicated by frequent disasters and emergencies worsening basic health services including surgical care. In these settings, postoperative pain remains underestimated and undertreated due to large patient numbers, high costs of common drugs like the opiate morphine etc. Many studies have proved that pre-emptive analgesia with ketamine is effective when combined with opiates but there is none demonstrating overall cost reduction. This study explored the effect of adding Intraoperative Low Dose Ketamine on overall cost of acute postoperative pain management (first 24 hours) with traditional intravenous morphine after major surgery in a low resource setting
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Post Operative Pain Management,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/03/2014
Actual trial start date 10/03/2014
Anticipated date of last follow up 20/06/2014
Actual Last follow-up date 20/06/2014
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
Recruitment status Completed
Publication URL Not published yet
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 Equal number of envelopes for each treatment group was prepared using a computerized random number generator by a study assistant who did not take part in any subsequent part of the study, and was not in contact with the rest of the study team throughout the study duration. identical sequentially numbered, opaque, sealed and stapled envelopes 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 Intraoperative Low dose ketamine ketamine 0.15mg/kg bolus at induction, and continuous infusion of 0.12ml/kg/hour till start of skin closure Duration of surgery Both groups; Morphine 0.1 mg/kg IV given at debulking. Blind observer assessed NRS pain score every 15min for first 1hr and every 4hrs for 24hours. If NRS >4, morphine was given in 2mg increments until NRS¿ 4. 23
Control Group Normal Saline 0.15mg/kg bolus at induction, and continuous infusion of 0.12ml/kg/hour till start of skin closure Duration of surgery Morphine 0.1 mg/kg IV given at debulking. Blind observer assessed NRS pain score every 15min for first 1hr and every 4hrs for 24hours. If NRS >4, morphine was given in 2mg increments until NRS¿ 4 23 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults; 18-70 years old ASA I and II scheduled for elective major surgery under General Anesthesia. Patients with chronic pain on regular medication with analgesics alcohol and drug abuse cases patients too sick to communicate patients with psychiatric disorders Obese patients Neurosurgery obstetrics and gynecology cases 18 Year(s) 70 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 10/01/2014 School of Medicine Research and Ethics Committee, Makerere University College of Health Sciences
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Overall cost of post-operative medications in the first 24hours after surgery; calculated and expressed in Uganda Shilling (UGX) at the end of study
Primary Outcome 2. Hospital length of stay from date of surgery. At time of patient discharge from hospital
Secondary Outcome side effects During data collection
Secondary Outcome Analgesic acceptance At the end of 24 hour monitoring
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago National Referral Hospital Mulago Hill Kampala Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Investigators Mulago National Referral Hospital Kampala Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Makerere University Department of Anaesthesia Makerere Hill Kampala Uganda University
COLLABORATORS
Name Street address City Postal code Country
RESEARCH CENTRE IN EMERGENCY AND DISASTER MEDICINE AND COMPUTER SCIENCE APPLIED TO MEDICAL PRACTICE Novara 28100, Italy NOVARA Italy
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Annet Alenyo aalenyo@yahoo.com +256 778 512 306
City Postal code Country Position/Affiliation
Kampala Uganda Medical Officer, Intensive Care Unit Mulago National Referral Hospital
Role Name Email Phone Street address
Public Enquiries Arthur Kwizera Kwizera.arthus@gmail.com +256 772897171 Mulago Hille
City Postal code Country Position/Affiliation
Kampala Uganda Medical Officer, Intensive Care Unit Mulago National Referral Hospital
Role Name Email Phone Street address
Scientific Enquiries Luca Ragazzoni luca.raggazoni@med.unipmn.it +39 3498761209 P. O. Box 7051, Mulago Hill
City Postal code Country Position/Affiliation
Kampala Uganda Anaesthesiologist , Medial Officer, Intensive Care Unit Mulago National Referral Hospital
REPORTING
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