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.: PACTR201404000807178 Date of Approval: 03/04/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ketamine and postoperative pain management
Official scientific title EFFECT OF 0.25MG/KG INTRAVENOUS KETAMINE DURING SPINAL ANAESTHESIA ON POST CAESAREAN ANALGESIC REQUIREMENT IN ELECTIVE CAESAREAN SECTIONS IN MULAGO, A RANDOMIZED CLINICAL TRIAL
Brief summary describing the background and objectives of the trial In obstetric anaesthesia, pain management is a very important component regardless of whether the mother is to have normal or operative delivery. Postoperative pain after caesarean delivery is unpleasant outcome for mothers which in turn affect their babies. Inadequate pain relief following a caesarean delivery results in delayed ambulation, discharge, inability to cough and inability to optimally care for her infant and therefore good pain control improves maternal satisfaction and decreases morbidity. Ketamine is cheap and readily available in Mulago hospital Many studies have shown that Ketamine in sub anaesthetic dose is a potent analgesic and is also effective in reducing opioid requirements 24 hours after surgery. Post-cesarean delivery morphine requirements in women who received ketamine as part of a general anesthesia technique were decreased Ketamine is used increasingly in sub-anaesthetic doses as adjuvant to local anaesthetics and opioids in multimodal pain therapy for acute pain management All current literature is from developed western countries; It¿s unclear if these study findings will be applicable to our setting. Currently no studies have been done in Uganda and East Africa concerning the possible beneficial analgesic effects of Ketamine in postoperative pain management Main Objective To determine whether 0.25mg/kg of intravenous Ketamine during elective caesarean section under spinal bupivacaine/fentanyl reduce analgesic requirements in the first 24 hours of delivery in elective caesarean section in Mulago hospital Specific Objectives ¿ To determine the time to break through pain in the first 24 hours following caesarean section delivery. ¿ To determine the pain scores at break through pain point of mothers in both arms ¿ To determine the total analgesic requirements in all mothers within 24hours
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Postoperative pain,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/04/2014
Actual trial start date 20/04/2014
Anticipated date of last follow up 06/06/2014
Actual Last follow-up date 06/06/2014
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants) 88
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
Open-label(Masking Not Used)
Open-label(Masking Not Used) Care giver/Provider,Outcome Assessors,Participants
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation( blocks of fours and fixed) Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised permuted block randomisation( blocks of fours and fixed) Sealed opaque envelopes Masking/blinding used
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ketamine 0.25mg/kg given before the first incision 44
Control Group placebo 0.25mg/kg given before the first incision 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Informed and consenting patients ¿ All Pregnant mothers scheduled for elective caesarean section under spinal anaesthesia ¿ ASA 1 and ASA 2 ¿ Hypertensive disorders ¿ Known clearly documented allergy to the study medication ¿ History of psychiatric disorders(hallucinations) ¿ Chronic opioid therapy ¿ Sickle cell disease ¿ Epilepsy ¿ Emergency obstetric cases ¿ Conversion to general anaesthesia 13 Year(s) 44 Year(s) Female
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 02/09/2013 School of medicine reseaech and ethics committee
Ethics Committee Address
Street address City Postal code Country
kampala P.O.BOX 7072,KAMPAL Uganda
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 02/09/2013 School of medicine reseaech and ethics committee
Ethics Committee Address
Street address City Postal code Country
kampala P.O.BOX 7072,KAMPAL Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time to breakthrough pain experienced by the patients in the first 24 hours following caesarean section delivery start counting immediately the spinal to the time when pain scale 3 or more
Primary Outcome The time to breakthrough pain experienced by the patients in the first 24 hours following caesarean section delivery measurement of pain immediately after the intervention and assessed every 30minutes till to first break through pain with pain score of 3 or more
Secondary Outcome Numeric pain score at break through pain Total analgesia requirement in the 24 hours immediately after institution of the intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mulago hospital kampala P.O. BOX 7051, Uganda
mulago hospital kampala P.O. BOX 7051, Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
SELF kampala P.O. BOX 7051, Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor SELF kampala P.O. BOX 7051, Uganda Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
mulago hospital kampala P.O. BOX 7051, Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator richard mwase drmwaserichard@gmail.com 0776117204
City Postal code Country Position/Affiliation
kampala P.O.BOX 7051 Uganda RESIDENT
Role Name Email Phone Street address
Public Enquiries JOHNMARK KASUMBA drkasmaya@gmail.com 0793625678
City Postal code Country Position/Affiliation
kampala P.O.BOX 7051 Uganda CONSULTANT
Role Name Email Phone Street address
Scientific Enquiries Daniel Obua obua.apunyo@yahoo.com 0792213416
City Postal code Country Position/Affiliation
kampala P.O.BOX 7051 Uganda lecturer
REPORTING
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