1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effectiveness of adernocorticotropin and aminophylline and caffeine;On the treatment of headache after tearing in patients with spinal aneshesia.

Protocol summary

Study aim
Evaluation the effectiveness of adernocortocotropine and aminophyline in comparison with caffeine in treatment of headache after dural punchture .
Design
Clinical trials with control group, with parallel groups, randomized in 90 patients.
Settings and conduct
Clinical trial, Ayatollah Mousavi Hospital, Zanjan,Iran
Participants/Inclusion and exclusion criteria
Participants aged 18to45 years with a headache that improves with sleep,no contraindication of steroid therapy and absence of migraine headache,have the entry requirements for the study..Participants are excluded from the study with dissatisfaction, history of cardiac arrhythmias and drugs allergy.
Intervention groups
Female patients aged 18-45 years who have a headache after spinal anesthesia for cesarean section and have criteria for entering the study, will be divided into three groups using randomized blocked random sampling. The first group of caffeine tablets 300 mg twice a day, the second group of muscle ACTH injections, and the third group of aminophylline ampoules 250 mg per 100 ml of normal saline will be given in half an hour. The patient's VAS will be measured before intervention, as well as at hours 1, 6, 12, 24, and 48 after intervention. Within 48 hours after the intervention, if the patient complains of headache failure and their VAS is greater than or equal to 4, additional accommodation will be prescribed. Satisfaction will also be measured. The need for admission and epidural epidural blood patch is recorded and compared among all three groups
Main outcome variables
Headache severity, satisfaction of patients, need for additional analgesic up to 48 hours after treatment

General information

Reason for update
Acronym
PDPH
IRCT registration information
IRCT registration number: IRCT20180325039148N4
Registration date: 2019-11-05, 1398/08/14
Registration timing: prospective

Last update: 2019-11-05, 1398/08/14
Update count: 0
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
Saeed Jalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0001
Email address
jalilis45@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of adernocorticotropin and aminophylline and caffeine;On the treatment of headache after tearing in patients with spinal aneshesia.
Public title
"Effect of caffeine, aminophylline and adrenocorticotropin on headache after spinal anesthesia"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
positinal Headache that is aggravated by lying down and exacerbate by sitting and standing lack of steroid contraindication including:hypertension,diabetes No drug or any other palliative during surgery No history of migraine or psychotic and neurological disease No history of caffeine allergy
Exclusion criteria:
Patient dissatisfaction Heart arrhythmias
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Mousavi Hosp. ,Gavazang Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2018-10-16, 1397/07/24
Ethics committee reference number
IR.ZUMS.REC.1397.186

Health conditions studied

1

Description of health condition studied
postdural puncture headache post cesarean section
ICD-10 code
O89.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during the puerperium

Primary outcomes

1

Description
Headache severity scale in VAS
Timepoint
At 0,1,6,12,24,48 hours intervals
Method of measurement
Visual Analog Scale questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Caffeine tablets 300 mg twice a day
Category
Treatment - Drugs

2

Description
Intervention group: 1 mg ACTH (synacthen, Iran hormones) intramuscular injection
Category
Treatment - Drugs

3

Description
Intervention group: Aminophylline Ampoules 250 mg (Sina Daru) Inside 100 ml normal
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Moosavi Hospital
Full name of responsible person
Saeed Jalili
Street address
Moosavi Hosp. ,Gavazang Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 1203
Email
jalilis45@zums.ac.ir
Web page address
http://zums.ac.ir/index.php?slc_lang=fa&sid=19

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shoghli Alireza
Street address
Moosavi Hospital ,Gavazang Blvd
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
jalilis45@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Moosavi Hospital ,Gavazang Blvd
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
jalilis45@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Moosavi Hospital ,Gavazang Blvd
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Fax
Email
jalilis45@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Saeed Jalili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Moosavi Hospital ,Gavazan Blvd.
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0001
Fax
Email
jalilis45@zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...