Home » Trials » SLCTR/2015/027
A randomized controlled trial on effectiveness of preemptive analgesia with paracetamol on reduction of occurrence of headache after Electro Convulsive Therapy (ECT)
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SLCTR Registration Number
SLCTR/2015/027
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A randomized controlled trial on effectiveness of preemptive analgesia with paracetamol on reduction of occurrence of headache after Electro Convulsive Therapy (ECT)
Public Title of Trial
Study on the effectiveness paracetamol two hours before Electro Convulsive Therapy (ECT) to reduce the incidence and severity of post ECT headache.
Disease or Health Condition(s) Studied
Post ECT headache
Scientific Acronym
None
Public Acronym
None
Brief title
Paracetamol as preemptive analgesia for post ECT headache
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
Faculty of Medicine, University of Kelaniya ERC no. P/166/10/2015
What is the research question being addressed?
Would pre-emptive treatment with paracetamol reduce the incidence and severity of post ECT headache compared to a placebo in patients receiving bilateral ECT?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study will be conducted among adult inpatients receiving electroconvulsive therapy (ECT) at the Colombo North Teaching Hospital, Ragama, Sri Lanka
Recruitment of patients will be done by non-clinical research assistants who are not involved in the treatment of the patient. The randomization to the treatment and control arm will be done remotely. Assignments in consecutively numbered sealed envelopes will be prepared by an independent statistician.
Participants of each arm will be randomized to receive a single dose of either 1g paracetamol or a matching placebo to be taken orally 2 hours before ECT.
Neither participants nor assessors will be aware whether they are getting placebo or medication. Nurses, would be requested to give either paracetamol or identical placebo by a research assistant who is aware of randomization. The placebo will be identical to paracetamol tablets used in the government sector by appearance, weight and texture and will be prepared by the State Pharmaceutical Manufacturing Cooperation, for the study.
Inclusion criteria
All adult patients receiving ECT at Colombo North Teaching Hospital during study period .
Exclusion criteria
Primary outcome(s)
|
1.
Incidence and severity of post E.C.T. headache using 1. visual analogue scale (Huskisson, 1974) 2. verbal descriptive scale (Keele, 1948) |
[ 2 hours after ECT ] |
Secondary outcome(s)
|
1.
Use of rescue analgesics |
[ 6 hours after ECT ] |
Target number/sample size
126 (63 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-12-15
Anticipated end date
2016-02-28
Date of first enrollment
2015-12-15
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2015-10-14
Approval number
P/166/10/2015
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Amila Isuru Lenduwa Lokuge
Senior Registrar in Psychiatry
University Psychiatry Unit,
North Colombo Teaching Hospital
Ragama
0777424850
amila.isuru23@gmail.com
Contact Person for Public Queries
Dr Asiri Rodrigo
Consultant Psychiatrist / Lecturer
Department of Psychiatry
Faculty of Medicine,
PO Box 6
Ragama
Tel: 0112961000
asirir2000@yahoo.com
Primary study sponsor/organization
Professorial Psychiatry Unit,
Ward 28/ 29
North Colombo Teaching Hospital
Ragama, Sri Lanka
Tel: +94112959261
http://www.kln.ac.lk/medicine/depts/phychiatry/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
