search
Back to results

Morphine Analgesia in Patients With Acute Appendicitis

Primary Purpose

Appendicitis

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Morphine
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Appendicitis focused on measuring MORPHINE, ANALGESIA, ACUTE APPENDICITS

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Sina General Hospital

Outcomes

Primary Outcome Measures

Pain Intensity

Secondary Outcome Measures

Diagnostic Accuracy

Full Information

First Posted
May 20, 2007
Last Updated
May 20, 2007
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT00477061
Brief Title
Morphine Analgesia in Patients With Acute Appendicitis
Official Title
Double Blind Randomized Study of Morphine Analgesia in Patients With Acute Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Analgesic administration for pain control in patients with acute abdominal pain, regarding acute appendicitis, is controversial. Despite the results previous studies indicating the safeness of analgesic use in ED for acute abdominal pain, physicians still prefer to postpone their use after performing surgical evaluations. Since many patients admitted to ED are unlikely to receive prompt surgical consultation, many of them need pain relief to prevent unnecessary suffering. On the other hand such pain relief must not interfere with the diagnosis and treatment of patients and do not cause any complications. Morphine is a common and effective analgesic which, if shown to have no effect on correct diagnosis of acute abdomen, can be used for this purpose. Thus we evaluated morphine effect on pain reduction and diagnostic accuracy in patients admitted to ED with the diagnosis of acute appendicitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
MORPHINE, ANALGESIA, ACUTE APPENDICITS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Morphine
Primary Outcome Measure Information:
Title
Pain Intensity
Secondary Outcome Measure Information:
Title
Diagnostic Accuracy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinical signs of acute appendicitis planned for appendectomy supposed to wait for at least 1 hour in the ED before operation Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asieh Golozar, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sina General Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
18723709
Citation
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.
Results Reference
derived

Learn more about this trial

Morphine Analgesia in Patients With Acute Appendicitis

We'll reach out to this number within 24 hrs