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.: PACTR201510001299332 Date of Approval: 09/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between Neostigmine and conventional method for treatment of Post Dural Puncture Headache
Official scientific title Comparison between Neostigmine and conventional method for treatment of Post Dural Puncture Headache
Brief summary describing the background and objectives of the trial post-dural puncture headache is a frequent complication facing patients and anesthetists after dural puncture following spinal anesthesia or complicated epidural anesthesia. many drugs and methods were applied to treat this condition with no definitive cure. neostigmine is an anticholine estrase that is being used in anesthetic practice to aid reversal of muscle relaxation. neostigmine has an antinociceptive effect and has been used in treatment of migraine which shares a mechanism of pathophysiology with the post dural puncture headache. we examined in our study whether neostigmine can be used as a treatment for post dural puncture headache or not
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,post dural puncture headache
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 26/03/2014
Actual trial start date 26/03/2014
Anticipated date of last follow up 16/02/2015
Actual Last follow-up date 08/09/2017
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 110
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 computer generated numbers opaque sealed envelope 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 neostigmine 1.25 mg single injection neostigmine 1.25 mg with 1 mg atropine were given as a single injection by slow intravenous injection over 10 minutes 45
Control Group conventional method caffien 500 mg twice daily 3 days caffien 500 mg twice daily with bed rest and fluids 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- age:21 to 50 years - post dural puncture headache - age less than 21 years or more than 50 years - suspected other cause of headache e.g. migraine - allergy to neostigmine - contraindicated atropine e.g. glucoma 21 Year(s) 50 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 25/03/2014 Faculty of Medicine-Beni Suef University
Ethics Committee Address
Street address City Postal code Country
mokbl street Beni Suef 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome treatment of post dural puncture headache every 6 hours for three days
Secondary Outcome absent recurrence of headache every 6 hours for 3 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef University hospital Mokbl street Beni Suef 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Beni Suef University Hospital Mokbl street Beni Suef 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni Suef University Hospital Mokbl street Beni Suef 11562 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdelaal Ahmed Mahmoud 39 mousa ebn nousir street cairo 11471 Egypt
mohamed mohamed abdelhaq Elmanial street cairo 11471 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdelaal Ahmed Mahmoud carnitin7@yahoo.com +201113308866 39 mousa ebn nousir street
City Postal code Country Position/Affiliation
cairo 11471 Egypt lecturer of anesthesiology, faculty of medicine, Beni Suef University
Role Name Email Phone Street address
Public Enquiries Ahmed Abdelaal Ahmed Mahmoud carnitin7@yahoo.com 00201113308866 39 mousa ebn nousir street
City Postal code Country Position/Affiliation
cairo 11471 Egypt lecturer of anesthesiology, faculty of medicine, Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdelhaq mohamedabdelhaq76@hotmail.com 00201000053764 almanial street
City Postal code Country Position/Affiliation
cairo 11471 Egypt lecturer of anesthesiology, faculty of medicine, Cairo University
REPORTING
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