NCT01546701

Brief Summary

The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

1.1 years

First QC Date

March 1, 2012

Last Update Submit

December 6, 2012

Conditions

Acute Pain ManagementRenal Colic

Outcome Measures

Primary Outcomes (1)

  • change in pain score

    change in pain severity based on Numerical Rating Score

    20 and 40 minutes

Secondary Outcomes (1)

  • treatment side effects

    40 minutes

Study Arms (2)

Buprenorphine

EXPERIMENTAL

Renal Colic Patients treated by 2 mg sublingual Buprenorphine.

Drug: Buprenorphine

Morphine

ACTIVE COMPARATOR

Renal Colic Patients treated by 0.1 mg/kg intravenous morphine.

Drug: Morphine

Interventions

BuprenorphineDRUG

2 mg sublingual tablet

Buprenorphine
MorphineDRUG

0.1 mg/kg IV morphine

Morphine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll.

You may not qualify if:

  • previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases;
  • febrile patients (T \> 38°C);
  • hemodynamically unstable patients ( Systolic Blood Pressure \< 90 mmHg);
  • pregnant patients;
  • patients with abdominal tenderness as a sign of peritoneal inflammation;
  • any clinical suspicion for diseases other than urolithiasis like abdominal aortic aneurysm or dissection;
  • patients with a history of drug addiction or known allergy to opioids;
  • patients who had used analgesics 6 hours before arriving.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TUMS

Tehran, Tehran Province, 1417613151, Iran

Location

MeSH Terms

Conditions

Renal Colic

Interventions

BuprenorphineMorphine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsMorphine Derivatives

Study Officials

  • Mohammad Jalili, MD

    TUMS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

IR(1)