NCT01123551

Brief Summary

In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults. It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than intravenous (IV) method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2010

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

May 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

4.1 years

First QC Date

May 11, 2010

Last Update Submit

July 22, 2014

Conditions

Post Traumatic Pain

Keywords

Nebulized morphineIntravenous morphinePost traumaticPainEmergency department

Outcome Measures

Primary Outcomes (1)

  • 1. Resolution rate

    resolution is defined as VAPS \<30%.

    one hour

Secondary Outcomes (2)

  • rate of side effects

    one hour

  • Resolution time

    one hour

Study Arms (2)

Nebulized Morphine

EXPERIMENTAL

After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .

Drug: nebulized morphineDrug: Intravenous morphine

Intravenous morphine

ACTIVE COMPARATOR

After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS \>30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS \>30%).

Drug: Intravenous morphine

Interventions

nebulized morphineDRUG

After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .

Nebulized Morphine
Intravenous morphineDRUG

After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS \>30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS \>30%).

Intravenous morphineNebulized Morphine

Eligibility Criteria

Age8 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Post-traumatic pain with visual analog pain scale( VAPS) ≥ 50%
  • Age between 8 and 50 years.

You may not qualify if:

  • Glasgow coma scale (GCS)\< 14,
  • Severe injury ,
  • Hypotension : blood systolic pressure \< 90 mmhg,
  • Bradypnea \< 12 cpm or SaO2\< 90%,
  • Chronic pain treatment,
  • Aspirin or paracetamol treatment within 6 hours of emergency presentation,
  • Nasal trauma, rhinitis, nasal obstruction,
  • Incapacity to cooperate,
  • Opiate allergy,
  • Drug addiction,
  • Pregnancy, breast feeding,
  • Severe renal and liver failure and chronic obstructive pulmonary disease(COPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fattouma Bourguiba University Hospital

Monastir, Monastir Governorate, 5000, Tunisia

Location

MeSH Terms

Conditions

PainEmergencies

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 14, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 23, 2014

Record last verified: 2014-07

Locations

TU(1)