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Effectiveness of apotel injection in renal colic patients

A clinical trial comparing the effects of apotel to normal saline on pain relief, need for narcotics, and side effects among renal colic patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016051425507N3
Enrollment
110
Registered
2016-05-25
Start date
2016-06-21
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. Unspecified renal colic

Interventions

Intervention 1: Control group: Renal colic patients will receive 1 g of IV normal saline with 0.05 mg/kg of IM morphine, and their level of pain will be assessed pre- and 30 minutes post-intervention
Treatment - Drugs
Control group: Renal colic patients will receive 1 g of IV normal saline with 0.05 mg/kg of IM morphine, and their level of pain will be assessed pre- and 30 minutes post-intervention based on Visual
Intervention group: Renal colic patients will receive 1 g of IV apotel (acetaminophen injection made of COMBINO PHARM company) with 0.05 mg/kg of IM morphine, and their level of pain will be assessed

Sponsors

Vice Chancellor for Research of Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Renal colic patients; having a weight between 50 and 80 kg; aged between 18 and 50 years. Exclusion criteria: History of allergy to narcotics or acetaminophen; chills and fever; urinary tract infection based on laboratory findings; history of drug abuse, receiving narcotics or other analgesics during six hours before admission; pregnancy; history of renal, cardiac, respiratory, or hepatic failure, history of renal transplantation; abdominal aortic aneurysm; history of hypertension or hemodynamic instability.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain level. Timepoint: Pre- and 30 minutes post-intervention. Method of measurement: Visual Analogue Scale (VAS).

Secondary

MeasureTime frame
Side-effects of pharmaceuticals, include nausea, vomiting, hypotension, itching and drowsiness. Timepoint: Half an hour after the intervention. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Sirous

Arak University of Medical Sciences

m-jiriaie@mscstu.scu.ac.ir+98 86 3313 6058

Outcome results

None listed

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