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Comparing the effect of morphine with combined morphine and naloxone on pain

Comparing the analgesic effects and complications of morphine plus very low dose of naloxone with morphine alone on renal colic patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017031923696N5
Enrollment
280
Registered
2017-08-17
Start date
2017-03-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal colic. Calculus of kidney,Calculus of lower urinary tract,Calculus of urinary tract in diseases classified elsewhere,Unspecified renal colic

Interventions

Intervention 1: Intervention group: Morphine, manufactured by Dr Abidi Laboratory, 0.1 mg/kg intravenous injection, at min 0 and min 20, and Naloxone, manufactured by Dr Abidi Laboratory, 0.001 mg/kg
Treatment - Drugs
Placebo
Intervention group: Morphine, manufactured by Dr Abidi Laboratory, 0.1 mg/kg intravenous injection, at min 0 and min 20, and Naloxone, manufactured by Dr Abidi Laboratory, 0.001 mg/kg intravenous inje
Intervention group: Morphine, manufactured by Dr Abidi Laboratory, 0.1 mg/kg intravenous injection, at min 0 and min 20, and distilled water, manufactured by Dr Abidi Laboratory, 5 ml, intravenous inj

Sponsors

Vice chancellor for research of Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
84 Years to 34 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: renal colic; the severity of pain according to VAS should be 7 to10. Exclusion criteria: pregnancy; allergies to medications used in the study; morphine contraindications; addicted to drugs; get analgesic in 6 hours prior to the study; the presence of symptoms of peritoneal in abdominal examination; history of cardiovascular disease; psychosis; unwillingness to participate in the study; acute ischemic disease; age over 60 years.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: At the beginning of the intervention, 20, 40, 60, 120, 180 min after intervention. Method of measurement: VAS Scoring (visual analogue scale).

Secondary

MeasureTime frame
Blood pressure. Timepoint: 0,20,40,60,120 and 180 min after intervention. Method of measurement: Mercury Sphygmomanometer.;Sedation. Timepoint: 0,20,40,60,120 and 180 min after intervention. Method of measurement: Ramsay sedation scale.;Nausea. Timepoint: 0,20,40,60,120 and 180 min after intervention. Method of measurement: VAS (visual analogue scale).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Muhammadian Amiri

Mazandaran University of Medical Sciences

Mhoseininejad@mazums.ac.ir; dr_muhammadian@yahoo.com+98 11 3335 5980

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026