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

• ClinicalTrials.gov Identifier: NCT01123551
• Recruitment Status: Completed
• First Posted: May 14, 2010
• Last Update Posted: July 23, 2014
• Sponsor: University of Monastir
• Information provided by (Responsible Party): Nouira, University of Monastir

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 (Clinical Trial)
• 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: June 2010
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 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 [ Time Frame: one hour ]
   resolution is defined as VAPS <30%.

Secondary Outcome Measures :

1. rate of side effects [ Time Frame: one hour ]
   Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.
2. Resolution time [ Time Frame: 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

• Ages Eligible for Study: 8 Years to 50 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Tunisia

Fattouma Bourguiba University Hospital

Monastir, Tunisia, 5000

Sponsors and Collaborators

University of Monastir

More Information

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

Keywords provided by Nouira, University of Monastir:

Nebulized morphine; Intravenous morphine; Post traumatic; Pain; Emergency department

Additional relevant MeSH terms:

Morphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents