Investigating the effect of intravenous calcium gluconate on the reduction of abdominal pain in patients with opioid ingestion who suspect lead contamination
Design
This study, which is a clinical trial study, will be performed in 50 patients with oral opium with a lead level above 20 referring to the emergency department of Afzalipour Kerman Hospital and poisoning in Loghman Hospital. The sampling will be easy and accessible. The study will be initially explained in terms of the process and objectives of the study and will be included in the study once written consent is formally completed.
Settings and conduct
This study, which is a clinical trial study, will be carried out in 50 patients with oral hypertension with a lead level of more than 20 who are referred to emergency department of Afzali Pourkerman Hospital and poisoning in Loghman Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1_Above 18 years old
2_Oral opium consumer with a lead level greater than 20
Exclusion criteria
1. Mental retardation
2- Neuropathic diseases such as diabetes
3. Chronic pain syndromes
4. High blood pressure and heart disease
5- Contraindications for calcium gluconate injection, including sensitivity to this group of drugs. Kidney stones. Hybercalcemia. Hipophosphatemia
6-pregnant patient
7-Patient with Asthma
8 - Patients suspected bowel obstruction or with sign of acute abdomen
9. History of Morphine Sensitivity
10-Other diagnosis other than lead poisoning
11. Use of psychiatric drugs
12. Chronic severe anemia
Intervention groups
patient who were injected morphine under cardiac monitoring and pulse oximetry where also recieved calcium gluconate
Main outcome variables
lead poisinig ; abdominal pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171009036661N2
Registration date:2018-05-27, 1397/03/06
Registration timing:retrospective
Last update:2018-05-27, 1397/03/06
Update count:0
Registration date
2018-05-27, 1397/03/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3335 6220
Email address
m.mayel@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-02, 1396/03/12
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
2017-06-02, 1396/03/12
Actual recruitment end date
2018-03-11, 1396/12/20
Trial completion date
empty
Scientific title
The effect of intravenous calcium gluconate on abdominal pain among oral opium users suspected to lead poisoning
Public title
Evaluation of calcium gluconate on reduction of abdominal pain caused by lead toxicity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old
Oral users of opioids with a lead level greater than 20
Exclusion criteria:
1. Mental retardation
Neuropathic diseases such as diabetes
Chronic pain syndromes
High blood pressure and heart disease
Contraindications for calcium gluconate injection, including sensitivity to this group of drugs. Kidney stones. Hypercalcemia. Hypophosphatemia.
pregnant patient
Patient with Asthma
Patients suspected of obstructive bowel obstruction or with acute abdominal symptoms
Other diagnosis other than lead poisoning
Use of psychiatric drugs
Chronic severe
History of Morphine Sensitivity
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
...
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be divided into two groups, the first group of patients who will be injected with morphine and normal saline for relief of abdominal pain, will be injected with cardiac monitoring and pulse oximetry, and 0.1 mg / kg of morphine will be given slowly to the patient, The second group was the patients who underwent cardiac monitoring and pulse oximetry of 10cc calcium gluconate after injection of morphine with a microtiter. Before injection, the VAS is determined in each patient. Then the medicine is prescribed. After injection, the VAS will be measured at 15 minutes, 30 minutes, and one hour later.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Somayyeh Crossroad (Tahmasebabad) , Beginning of Jihad Boulevard
City
kerman
Province
Kerman
Postal code
7613747181
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.KMU.REC.1396.2116
Health conditions studied
1
Description of health condition studied
Lead toxicity in opium addicted patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
lead colic
Timepoint
15 minutes, 30 minutes and an hour later
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who underwent cardiac monitoring and pulsed oximetry of 10cc calcium gluconate after injection of morphine with a microtiter. Before injection, the VAS is determined in each patient. Then the medicine is prescribed. After injection, the VAS will be measured at 15 minutes, 30 minutes, and one hour later.
Category
Treatment - Drugs
2
Description
Control group: : Patients who received morphine 0.1 mg / kg and normal saline with micro-set for relief of abdominal pain which will be injected under cardiac monitoring and pulse oximetery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman hakim hospital
Full name of responsible person
Hasan hasaneian
Street address
Four Way Makhsoos Streets Unit , Loghman Hakim Hospital
City
Tehran
Province
Tehran
Postal code
1333631151
Phone
+98 21 5541 9005
Fax
+98 21 5541 7547
Email
loghman.hospital@sbmu.ac.i
2
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Masoud Mayel
Street address
Imam Highway
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3325 7651
Email
masoud.mayel@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
dr. pardakhti
Street address
Tahmasebabad Four Way Deputy of research and technology
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
National Garden Square . Qarani Street
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
National Garden Square. Qarani Street
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
National Garden Square. Qarani Street
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available