Evaluation of calcium gluconate on reduction of abdominal pain caused by lead toxicity

• Register: IRCT
• Last refreshed on: 18 June 2018
• Main ID: IRCT20171009036661N2
• Date of registration: 2018-05-27
• Prospective Registration: No
• Primary sponsor: Kerman University of Medical Sciences
• Public title: Evaluation of calcium gluconate on reduction of abdominal pain caused by lead toxicity
• Scientific title: The effect of intravenous calcium gluconate on abdominal pain among oral opium users suspected to lead poisoning
• Date of first enrolment: 2017-06-02
• Target sample size: 50
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/29864
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: , 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.
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr. Massoud mayel
• Affiliation: Kerman University of Medical Sciences

• Name: Dr. Massoud mayel
• Affiliation: Kerman University of Medical Sciences

Key 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 minimum: 18 years
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

Lead toxicity in opium addicted patients.

Intervention(s)

Intervention 1: 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. Intervention 2: 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.

Primary Outcome(s)

Lead colic. Timepoint: 15 minutes, 30 minutes and an hour later. Method of measurement: Visual Analogue Scale.

Source(s) of Monetary Support

Kerman University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Kerman University of Medical Sciences