Clinical Trial for the assessment of treatment efficacy with a gas mixture of equal parts (50/50) of nitrous oxide (N2O) and oxygen (O2) in renal colic.

• Conditions: RENAL COLIC; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-000200-15-ES
• Lead Sponsor: Fundación de Investigación Biomédica. Instituto de Investigación Sanitaria del Hospital Universitario de la Princesa.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 25 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

Age ? 18 years.
Low back pain irradiated or not.
Colic in nature.
Pain by pressure in the same side of pain.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 242
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients <18 years.
? Patients who do not meet criteria for the diagnosis of renal colic.
? Patients with allergy or intolerance to either drug used in the study (dexketoprofen, metamizol, metoclorpropamida and / or pethidine).
Pregnant patients, applying the usual clinical management of patients with suspected renal colic. Be considered as not pregnant the patient who has not presented late in their menstrual cycle and that denies the possibility of pregnancy and / or using effective contraception or menopausal patient.
? breast feeding patients.
? Patients with clinically significant psychiatric condition at the discretion of the physician.
? Patients with absolute or relative contraindication for the use of N2O/O2 50/50:
or unable to work and / or altered level of consciousness.
o pneumothorax.
or with significant abdominal distension and / or suspected bowel obstruction.
o severe bullous emphysema.
or a history of recent diving (in the last 7 days).
or have suffered a head injury.
o those who have made recent intraocular injection of gas (in the last 7 days).
o which they have made a surgical procedure in the middle ear.
or oxygen saturation <94%.
o known deficiency of vitamin B12 or folic

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified