NCT00477061

Brief Summary

The purpose of the study is to evaluate morphine effect on pain reduction and diagnostic accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2004

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

January 1, 2004

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
Last Updated

May 22, 2007

Status Verified

May 1, 2007

First QC Date

May 20, 2007

Last Update Submit

May 20, 2007

Conditions

Appendicitis

Keywords

MORPHINEANALGESIAACUTE APPENDICITS

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

Secondary Outcomes (1)

  • Diagnostic Accuracy

Interventions

MorphineDRUG

Eligibility Criteria

Age13 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinical signs of acute appendicitis
  • planned for appendectomy
  • supposed to wait for at least 1 hour in the ED before operation

You may not qualify if:

  • suspicion to perforated appendicitis
  • being under the age of 13
  • pregnancy (according to history and ß-HCG result)
  • opium addiction
  • systolic blood pressure of less than 90 mmHG
  • known cases of chronic obstructive pulmonary disease (COPD)
  • known sensitivity to morphine
  • history of sickle cell disease
  • self administration of analgesics before enrollment
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sina General Hospital

Tehran, Tehran Province, Iran

Location

Related Publications (1)

  • Amoli HA, Golozar A, Keshavarzi S, Tavakoli H, Yaghoobi A. Morphine analgesia in patients with acute appendicitis: a randomised double-blind clinical trial. Emerg Med J. 2008 Sep;25(9):586-9. doi: 10.1136/emj.2007.050914.

    PMID: 18723709DERIVED

MeSH Terms

Conditions

AppendicitisAgnosia

Interventions

Morphine

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Asieh Golozar, MD

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2007

First Posted

May 22, 2007

Study Start

January 1, 2004

Study Completion

March 1, 2005

Last Updated

May 22, 2007

Record last verified: 2007-05

Locations

IR(1)