Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain
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ClinicalTrials.gov Identifier: NCT01123551 |
Recruitment Status :
Completed
First Posted : May 14, 2010
Last Update Posted : July 23, 2014
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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 |
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Post Traumatic Pain | Drug: nebulized morphine Drug: Intravenous morphine | Phase 3 |
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 |

Arm | Intervention/treatment |
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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 .
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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%).
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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%). |
- 1. Resolution rate [ Time Frame: one hour ]resolution is defined as VAPS <30%.
- rate of side effects [ Time Frame: one hour ]Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.
- 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%

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Ages Eligible for Study: | 8 Years to 50 Years (Child, Adult) |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123551
Tunisia | |
Fattouma Bourguiba University Hospital | |
Monastir, Tunisia, 5000 |
Responsible Party: | Nouira, Professor, University of Monastir |
ClinicalTrials.gov Identifier: | NCT01123551 |
Other Study ID Numbers: |
Morphine |
First Posted: | May 14, 2010 Key Record Dates |
Last Update Posted: | July 23, 2014 |
Last Verified: | July 2014 |
Nebulized morphine Intravenous morphine Post traumatic Pain Emergency department |
Morphine Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |