Low Back PainPhase 4NCT01129934
Morphine Versus Morphine-promethazine Combination for Acute Low Back Pain Relief in the Adult Emergency Department
A Phase 4 study testing Morphine-Promethazine and morphine in people with Low Back Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Acute low back pain is a common cause for emergency department visits. Controversy remains regarding the optimal medication for acute low back pain relief. The investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Morphine-Promethazine and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to Jan 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An indication for opioid analgesia based in the ED (i.e. severe pain > 70mm on a 100mm VAS)
- Age between 18-65 years
- American Society of Anesthesiologists (ASA) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease
- Systolic blood pressure higher than 90 mmHg on admission
- Willingness and ability to provide an informed consent
- No known hypersensitivity to the medication used.
Who cannot join
- Pregnant women
- Patients who can not be under adult supervision following discharge from the emergency department.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel-Aviv Sourasky Medical Center
Tel Aviv
Ofir Uri, M.D, 972-52-4262285, ofiruri@gmail.com
Pinchas Halpern, M.D, 972-52-4266681, dr_halperin@tasmc.health.gov.il
About this study
Official title: Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department
Acute low back pain is a common cause for emergency department visits. Controversy remains regarding the optimal medication for acute low back pain relief. The investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the emergency department.
Read the detailed description
Acute low back pain is a common problem in the emergency department and pain relief is usually the first step in patients' management. Numerous medication options are available for acute LBP relief,each class of medication has its associated benefits and harms.Controversy remains regarding the optimal analgesic treatment.Anxiety has been found to be a predictive factor of pain intensity in patients with acute low back pain and anxiolysis by non-pharmacological measures has been shown to have a positive effect on pain management in the ED setting.
Promethazine is a first-generation H1 receptor antagonist of the phenothiazine chemical class used commonly as an antihistamine antiemetic. It has a strong anxiolytic-sedative effect and its safety and efficacy in managing anxiety related to medical procedures is well documented.It may be reasonable to assume that pharmacological anxiolysis with promethazine may assist in alleviation of acute pain in the strenuous environment of the ED.
- Conditions
- Low Back Pain
- Being tested
- Morphine-Promethazine, morphine
- Keywords
- Low Back Pain,, Emergency medicine,, Promethazine,, Morphine,, Pain relief
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine-PromethazineDrug
Also called morphine-phenergan
administration of intravenous morphine 0.1mg/kg and promethazine 12.5 mg in a 500 Ml 0.9% saline
morphineDrug
Also called morphine as a single drug
Administration of intravenous morphine 0.1 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Morphine-Promethazine | Experimental | Pain relief by administration of morphine-promethazine combination Receives: Drug: Morphine-Promethazine |
| morphine | Active comparator | pain relief by administration of morphine Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.
Measured: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)
Secondary outcomes (1)
Ambulatory status
Most patients who suffer from acute LBP are in severe pain and are unable to ambulate. The ambulatory status of every patient (e.g., able to walk independently, using a can, wheelchair, laying down and unable to sit or stand up)will be recorded before and after treatment.
Measured: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Pinchas Halpern, M.D, Study chair, Tel-Aviv Medical Center, Tel-Aviv University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129934
- Sponsor's protocol ID
- TASMC-09-PH-701-CTIL
- Status last verified
- May 2010
- First submitted
- 21 Apr 2010
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department
- ClinicalTrials.gov ID
- NCT01129934
- Acronym / sponsor ID
- TASMC-09-PH-701-CTIL
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain,, Emergency medicine,, Promethazine,, Morphine,, Pain relief
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 25 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute low back pain is a common cause for emergency department visits. Controversy remains regarding the optimal medication for acute low back pain relief. The investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the emergency department.
Detailed description
Acute low back pain is a common problem in the emergency department and pain relief is usually the first step in patients' management. Numerous medication options are available for acute LBP relief,each class of medication has its associated benefits and harms.Controversy remains regarding the optimal analgesic treatment.Anxiety has been found to be a predictive factor of pain intensity in patients with acute low back pain and anxiolysis by non-pharmacological measures has been shown to have a positive effect on pain management in the ED setting.
Promethazine is a first-generation H1 receptor antagonist of the phenothiazine chemical class used commonly as an antihistamine antiemetic. It has a strong anxiolytic-sedative effect and its safety and efficacy in managing anxiety related to medical procedures is well documented.It may be reasonable to assume that pharmacological anxiolysis with promethazine may assist in alleviation of acute pain in the strenuous environment of the ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine-Promethazine | Experimental | Drug: Morphine-PromethazinePain relief by administration of morphine-promethazine combination |
| morphine | Active comparator | Drug: morphinepain relief by administration of morphine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- An indication for opioid analgesia based in the ED (i.e. severe pain > 70mm on a 100mm VAS)
- Age between 18-65 years
- American Society of Anesthesiologists (ASA) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease
- Systolic blood pressure higher than 90 mmHg on admission
- Willingness and ability to provide an informed consent
Key exclusion criteria (2 listed)
- Pregnant women
- Patients who can not be under adult supervision following discharge from the emergency department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine-PromethazineAlso: morphine-phenerganadministration of intravenous morphine 0.1mg/kg and promethazine 12.5 mg in a 500 Ml 0.9% saline | Drug | Morphine-Promethazine |
| morphineAlso: morphine as a single drugAdministration of intravenous morphine 0.1 mg/kg | Drug | morphine |
Primary outcome
Pain relief
Time frame: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)
Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.
1 secondary outcome
Ambulatory status
Time frame: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinchas Halpern, M.D study chair
Tel-Aviv Medical Center, Tel-Aviv University, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine-Promethazine and morphine in people with Low Back Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofir Uri, M.D (972-52-4262285, ofiruri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2010.