Penthrox Versus Tramadol for SCDF (PENTRA)
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|ClinicalTrials.gov Identifier: NCT01887951|
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : February 10, 2017
Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It is common for a delay in administration of analgesia. Inhaled methoxyflurane (Penthrox) is a potential agent for early administration of analgesia by Singapore Civil Defense Force (SCDF) EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use as an analgesic agent in general are limited and there are few published controlled trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used in the hospital setting for analgesia. It is well proven, simple to deliver and is not a controlled drug.
To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by the SCDF EAS.
The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol). Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility criteria will be recruited into the study. Half of SCDF's 30 ambulances (15 ambulances), will be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other half (15 ambulances), will be trained and equipped with tramadol. Allocation will be on a per station level. After 6 months, they will cross over to Penthrox and tramadol respectively.
All paramedics will be trained to use both medications, pain scales and Ramsey scores, and will record patient's pain, sedation scores and patient satisfaction as part of routine clinical practice. All patients will be followed up by a review of their Emergency Department and hospital records for any medication related adverse effects.
The investigators hypothesize that in patients with acute pain (pain score ≥3), presenting to the ambulance service with musculo-skeletal trauma (limbs or back); pain relief by inhaled methoxyflurane will be equivalent to IM tramadol, as assessed by Visual Analogue Scale (VAS) at 5, 10, 15 and 20 min after start of the study treatments.
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Drug: Penthrox Inhaler Drug: Tramadol Injection||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||380 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Clinical Evaluation of Penthrox (Methoxyflurane)and Tramadol for the Singapore Emergency Ambulance Service|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||October 2015|
Active Comparator: Tramadol
Tramadol HCL. Dosage form: Injection Strength: 50mg/ampoule Frequency: 1 time
Drug: Tramadol Injection
Dosage form: Inhalation; Strength: 3ml/bottle; Frequency: Up to 6ml per day. Total weekly dose should not exceed 15ml.
Drug: Penthrox Inhaler
- Change in Pain Score assessed by Visual Analogue Scale (VAS) [ Time Frame: 5, 10, 15 and 20 min ]
- Change in Ramsay sedation Scores [ Time Frame: 5, 10, 15 and 20 min ]
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): NCT01887951
|Singapore Civil Defence Force|