Comparing the Analgesic Effect of Intravenous Acetaminophen and Morphine on Patients With Renal Colic Pain Reffering to the Emergency Department: A Randomized Controlled Trial

NCT01906762 | Completed Phase 2 DMC

• 1 other identifier: 389456
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

Kidney stone is one of the most common diseases in every human society and also Iran. What is normally used to treat renal colic pain is Intravenous Opioid with a variety of side effects including hypotension, respiratory depression and apnea, nausea and vomiting. Regarding less complications of Intravenous Acetaminophen, we aimed to compare it with Intravenous Morphine in management of renal colic pain.

Conditions

Renal Colic

Keywords

Morphine, Acetaminophen, Renal colic, Emergency treatment

Outcome Measures

Primary Outcomes (1)

• Pain

  patient's pain was assessed by using a Visual Analog Scale Ruler, that rates the amount of pain from 0 to 10 based on patient's confession. Patient's pain was checked out twice: exactly before receiving the pain reliever, and 30 minutes later.

  30 Minutes

Study Arms (2)

Acetaminophen

EXPERIMENTAL

Specified dosage for Acetaminophen was 15 mg/kg. so based on the patient's weight(averagely 70 kg), about 1gr Acetaminophen (one complete Apotel Ampule) was used.

Drug: Acetaminophen

Morphine

EXPERIMENTAL

Specified dosage for Morphine was 0.1 mg/kg. so based on the patient's weight(averagely 70 kg), about 7 mg Morphine was used.

Drug: Morphine

Interventions

Acetaminophen DRUG

This protocol prepared by a nurse and labeled as Drug A. Since the rapid injection of Acetaminophen can result in hypotension, therefore based on the Apotel Injection Instruction, it must be infused slowly within 15 minutes.

Also known as: Apotel

Acetaminophen

Morphine DRUG

This protocol was prepared by a nurse and labeled as Drug B. Since the rapid injection of Morphine can result in histamine release, therefore it must be infused slowly within 15 minutes. The nurse, who was in charge of infusing pain reliever, was unaware of the type of injected drug.

Also known as: Morphine Sulfate

Morphine

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 15 to 80 years
• weight of 60 to 80 kilograms
• known case of renal colic based on physical examination and Ultrasonography

You may not qualify if:

• Addiction
• allergic to Opioids and Acetaminophen
• receiving any types of analgesic drugs within previous 6 hours
• known cases of Kidney transplantation
• Patients with known heart failure
• Patients with known Liver failure
• Patients with known Respiratory failure
• Patients with known Renal failure
• cases of Blindness and physical disabilities not able to communicate

Sponsors & Collaborators

• Seyed Mehdi Pourafzali: lead

MeSH Terms

Conditions

Renal Colic

Interventions

Acetaminophen; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Emergency Medicine Specialist

Study Record Dates

• First Submitted: July 20, 2013
• First Posted: July 24, 2013
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 24, 2013

Record last verified: 2013-07