Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain

• Sponsor: University of Monastir (Other)
• Overall Status: Completed
• CT.gov ID: NCT01123551
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Pain	Drug: nebulized morphine; Drug: Intravenous morphine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nebulized Morphine 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 morphine; 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: Intravenous morphine; 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%).
Active Comparator: Intravenous morphine 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; 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%).

Outcome Measures

Primary Outcome Measures

1. 1. Resolution rate [one hour]

   resolution is defined as VAPS <30%.

Secondary Outcome Measures

1. rate of side effects [one hour]

   Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.

2. Resolution time [one hour]

   Resolution time is defined as the time between the starting of the protocol and pain decrease to a Visual Analog Scale less than 30%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Post-traumatic pain with visual analog pain scale( VAPS) ≥ 50%

• Age between 8 and 50 years.

Exclusion Criteria:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fattouma Bourguiba University Hospital	Monastir		Tunisia	5000

Sponsors and Collaborators

• University of Monastir

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nouira, Professor, University of Monastir
• ClinicalTrials.gov Identifier: NCT01123551
• Other Study ID Numbers: Morphine
• First Posted: May 14, 2010
• Last Update Posted: Jul 23, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Nouira, Professor, University of Monastir: Nebulized morphine; Intravenous morphine; Post traumatic; Pain; Emergency department
• Additional relevant MeSH terms: Morphine

Study Results

No Results Posted as of Jul 23, 2014