Penthrox Versus Tramadol for SCDF

NCT01887951 | Completed Phase 4

• 1 other identifier: CIRB 2013/044/C
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score assessed by Visual Analogue Scale (VAS)

  5, 10, 15 and 20 min

Secondary Outcomes (1)

• Change in Ramsay sedation Scores

  5, 10, 15 and 20 min

Study Arms (2)

Tramadol

ACTIVE COMPARATOR

Tramadol HCL. Dosage form: Injection Strength: 50mg/ampoule Frequency: 1 time

Drug: Tramadol Injection

Penthrox

EXPERIMENTAL

Dosage form: Inhalation; Strength: 3ml/bottle; Frequency: Up to 6ml per day. Total weekly dose should not exceed 15ml.

Drug: Penthrox Inhaler

Interventions

Penthrox Inhaler DRUG

Penthrox

Tramadol Injection DRUG

Tramadol

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore Civil Defence Force

Singapore, Singapore

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 27, 2013
• Study Start: February 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2015
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

SG (1)