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Trial record 55 of 456 for:    TRAMADOL

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
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

Introduction

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.

Aim

To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by the SCDF EAS.

Methodology

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.

Hypothesis

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: Tramadol
Tramadol HCL. Dosage form: Injection Strength: 50mg/ampoule Frequency: 1 time
Drug: Tramadol Injection
Experimental: Penthrox
Dosage form: Inhalation; Strength: 3ml/bottle; Frequency: Up to 6ml per day. Total weekly dose should not exceed 15ml.
Drug: Penthrox Inhaler



Primary Outcome Measures :
  1. Change in Pain Score assessed by Visual Analogue Scale (VAS) [ Time Frame: 5, 10, 15 and 20 min ]

Secondary Outcome Measures :
  1. Change in Ramsay sedation Scores [ Time Frame: 5, 10, 15 and 20 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute pain, with pain score greater than 3, presenting with musculo-skeletal trauma (limbs or back) pain are eligible
  • Conscious, haemodynamically stable condition (BP greater than 90/60)
  • Age more than 16 years old

Exclusion Criteria:

General

  • Females who are nursing or with a positive pregnancy test (pregnant)
  • Patients with major head injury or impaired consciousness
  • Acute intoxication with drugs or alcohol, or other conditions that might impair ability to score pain
  • Chronic pain requiring ongoing use of analgesics
  • Abdominal or chest pain (for the purpose of this initial implementation study)

Penthrox only

  • Known pre-existing renal or hepatic impairment
  • Hypersensitivity to fluorinated anaesthetics or a history of possible adverse reactions in either the patients or relatives (malignant hyperthermia)
  • Concomitant use of nephrotoxic medications such as gentamicin or tetracycline

Tramadol only

  • Any allergies to tramadol or codeine
  • Any history of seizures, epilepsy
  • Patients who are taking anti-depressants

Information from the National Library of Medicine

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


Locations
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Singapore
Singapore Civil Defence Force
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01887951     History of Changes
Other Study ID Numbers: CIRB 2013/044/C
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Tramadol
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents