The aim of the current study is to compare the efficacy of inhalational Entonox and parentral Morphine sulfate in patients with renal colic. We would include a total number of 100 patients with ultrasonography and CT-Scan confirmed nephrolithiasis leading to renal colic referring to our center. Those with morphin and Entonox sensitivity, those with chronic respiratory disease and those wiht ischemic heart diseases would be excluded. Patients would be randomly assigned to receive morphin injection (0.1 mg/kg) along with diclofenac suppository (100 mg) (n=50), or Entonox inhalation (containing 50% nitrous oxide, self-administration, in 30 minutes with mask) along with diclofenac suppository (100 mg). The pain severity would be measured at 3, 5, 10, 30 and 120 minutes after the operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120215620N4
Registration date:2015-05-11, 1394/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-11, 1394/02/21
Registrant information
Name
Alireza Majidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4407 2074
Email address
pezeshkmajidy@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Shahid Beheshti UNiversity of Medical Sciences
Expected recruitment start date
2012-12-29, 1391/10/09
Expected recruitment end date
2015-04-05, 1394/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic Effects of Inhalation of Entonox and Parentral Morphine Sulfate in Patients with Renal Colic; A Randomized Clinical Trial
Public title
Effects of Inhalation of Entonox and Parentral Morphine Sulfate in Patients with Renal Colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 20-50 years; acute renal colic conformed by both ultrasonography and abdominopelvic CT-Scan
Exclusion criteria: Pregnancy; asthma; chronic pulmonary obstructive disease (COPD); intestinal obstruction; hypertension; congestive heart failure; a history of surgery on kidneys and the urinary tract; peptic ulcers and gastrointestinal hemorrhage; allergy to aspirin, NSAIDs and morphine; decreased level of consciousness, head and thoracic trauma; pneumocephalus; pneumothorax (or entrapment of air in any part of the body); drug abuse; tenderness and rebound tenderness, abdominal guarding; delayed menstruation; use of any analgesic during the previous 24 hours and at entry into the emergency ward
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Shahid Beheshti University of Medical Sciences