Adult Oral Ibuprofen Study for ED Pain Patients
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 12/14/2018 |
| Start Date: | November 1, 2018 |
| End Date: | December 30, 2019 |
| Contact: | Antonios Likourezos, MA, MPH |
| Email: | alikourezos@maimonidesmed.org |
| Phone: | 718-283-6896 |
A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Oral Ibuprofen in Management of Mild to Moderate Pain in Adult Patients in the ED
Ibuprofen is one of the most widely used non-steroidal anti-inflammatory drug (NSAID) for
management of mild -to moderate pain in the ED (acute musculo-skeletal pain, headache, dental
pain). Ibuprofen as a representative of NSAID's as a class follows the analgesic ceiling
concept that postulates that there is a dose of a drug beyond which any further dosage
increase results in no additional analgesic effect. Despite this fact, Ibuprofen may commonly
be used at doses above its analgesic ceiling, although this may not offer an incremental
analgesic advantage and potentially adds risk of harm. The analgesic ceiling dose for
ibuprofen is only 200-400mg/dose, and about 1200 mg/day. Thus, we hypothesize that
administration of Ibuprofen in a dose of 400 mg in the ED is as effective in treating
mild-to-moderate acute pain in patients presenting to the ED as 600 mg and 800 mg
management of mild -to moderate pain in the ED (acute musculo-skeletal pain, headache, dental
pain). Ibuprofen as a representative of NSAID's as a class follows the analgesic ceiling
concept that postulates that there is a dose of a drug beyond which any further dosage
increase results in no additional analgesic effect. Despite this fact, Ibuprofen may commonly
be used at doses above its analgesic ceiling, although this may not offer an incremental
analgesic advantage and potentially adds risk of harm. The analgesic ceiling dose for
ibuprofen is only 200-400mg/dose, and about 1200 mg/day. Thus, we hypothesize that
administration of Ibuprofen in a dose of 400 mg in the ED is as effective in treating
mild-to-moderate acute pain in patients presenting to the ED as 600 mg and 800 mg
STUDY DESIGN A randomized, double-blind trial to determine the analgesic equivalency of
orally administered ibuprofen at 400 mg for the treatment of acute pain in comparison to with
higher doses of 600 and 800 mg for managing mild-to-moderate pain of adult patients in the
ED.
OUTCOME MEASURES The primary outcome will be reduction in numeric rating scale pain score at
60 minutes from medication administration. Secondary outcomes included rates and percentages
of subjects experiencing adverse effects as well as percentage of patients requiring rescue
analgesia
STUDY POPULATION Patients considered for inclusion will comprise adults aged 18 and older
years who presented to the ED primarily for management of acute mild to moderate
musculoskeletal pain, headache, or dental pain who would routinely be treated with oral
iburpofen in our ED as determined by the treating attending or resident physician. Acute pain
will be defined in our study as having an onset within 30 days or less. Exclusion criteria
will include pregnancy or breastfeeding, active peptic ulcer disease, acute gastrointestinal
hemorrhage, known history of severe renal or hepatic insufficiency, allergy to nonsteroidal
anti-inflammatory drugs, and patients having already received analgesic medication. For the
purposes of this study, ibuprofen will be used without co-administration of any other
analgesics, with the exception of rescue medication.
STUDY LOCATION The study will be conducted at a 711-bed urban community teaching hospital
with an annual ED census of greater than 120,000 visits.
DURATION OF ENROLLMENT Patients pain scores will be recorded at the beginning of the study
and at 60 minutes post-administration of medication by utilizing NRS.
DESCRIPTION OF INTERVENTION AND ADMINISTRATION Once the patient is triaged, an initial pain
score will be assessed. Patients will then have an initial evaluation by ED physician and,
once deemed eligible for the study, the patient will be randomized to receive oral ibuprofen
at a dose of 400mg, 600mg, or 800mg. The on-duty ED pharmacist will prepare 400 mg, 600 mg
and 800 mg oral ibuprofen preparations in identical capsules according to predetermined
randomization generated in SPSS by the research manager. Demographics, chief complaint and
initial pain score will be recorded in the data sheet as well as prior analgesics use.
Patients pain scores will be recorded at the beginning of the study and at 60 minutes
post-administration by using NRS.
RANDOMIZATION/BLINDING The research manager and statistician independently of data collection
will conduct the programming of the randomization list, confirmation of written consent
acquisition, and statistical analyses. ED pharmacy investigators will maintain the
randomization list, prepare the medication, and deliver it to the nurse caring for the study
participant in a blinded manner. The preparing pharmacist, research manager, and statistician
will be the only ones with knowledge of the study arm to which the participant would be
randomized. Providers, participants, and the data-collecting research team will be blinded to
the medication received. Study investigators will include treating physicians who will
assisted in screening and supervising the research fellow, residents, and research
coordinators, who will enroll patients and record pain scores and adverse effects at baseline
and at 60 minutes.
orally administered ibuprofen at 400 mg for the treatment of acute pain in comparison to with
higher doses of 600 and 800 mg for managing mild-to-moderate pain of adult patients in the
ED.
OUTCOME MEASURES The primary outcome will be reduction in numeric rating scale pain score at
60 minutes from medication administration. Secondary outcomes included rates and percentages
of subjects experiencing adverse effects as well as percentage of patients requiring rescue
analgesia
STUDY POPULATION Patients considered for inclusion will comprise adults aged 18 and older
years who presented to the ED primarily for management of acute mild to moderate
musculoskeletal pain, headache, or dental pain who would routinely be treated with oral
iburpofen in our ED as determined by the treating attending or resident physician. Acute pain
will be defined in our study as having an onset within 30 days or less. Exclusion criteria
will include pregnancy or breastfeeding, active peptic ulcer disease, acute gastrointestinal
hemorrhage, known history of severe renal or hepatic insufficiency, allergy to nonsteroidal
anti-inflammatory drugs, and patients having already received analgesic medication. For the
purposes of this study, ibuprofen will be used without co-administration of any other
analgesics, with the exception of rescue medication.
STUDY LOCATION The study will be conducted at a 711-bed urban community teaching hospital
with an annual ED census of greater than 120,000 visits.
DURATION OF ENROLLMENT Patients pain scores will be recorded at the beginning of the study
and at 60 minutes post-administration of medication by utilizing NRS.
DESCRIPTION OF INTERVENTION AND ADMINISTRATION Once the patient is triaged, an initial pain
score will be assessed. Patients will then have an initial evaluation by ED physician and,
once deemed eligible for the study, the patient will be randomized to receive oral ibuprofen
at a dose of 400mg, 600mg, or 800mg. The on-duty ED pharmacist will prepare 400 mg, 600 mg
and 800 mg oral ibuprofen preparations in identical capsules according to predetermined
randomization generated in SPSS by the research manager. Demographics, chief complaint and
initial pain score will be recorded in the data sheet as well as prior analgesics use.
Patients pain scores will be recorded at the beginning of the study and at 60 minutes
post-administration by using NRS.
RANDOMIZATION/BLINDING The research manager and statistician independently of data collection
will conduct the programming of the randomization list, confirmation of written consent
acquisition, and statistical analyses. ED pharmacy investigators will maintain the
randomization list, prepare the medication, and deliver it to the nurse caring for the study
participant in a blinded manner. The preparing pharmacist, research manager, and statistician
will be the only ones with knowledge of the study arm to which the participant would be
randomized. Providers, participants, and the data-collecting research team will be blinded to
the medication received. Study investigators will include treating physicians who will
assisted in screening and supervising the research fellow, residents, and research
coordinators, who will enroll patients and record pain scores and adverse effects at baseline
and at 60 minutes.
Inclusion Criteria:
- Adult ED patients aged 18 and older
- Chief complaint of mild to moderate musculoskeletal pain, headache, or dental pain
intensity of less than 4 on a standard 0 to 10 numeric rating scale.
- Acute pain (within 30 days of onset)
- Patients who would routinely be treated with oral ibuprofen
Exclusion Criteria:
- pregnancy or breastfeeding,
- active peptic ulcer disease,
- acute gastrointestinal hemorrhage,
- known history of severe renal or hepatic insufficiency, allergy to nonsteroidal
anti-inflammatory drugs,
- patients having already received analgesic medication.
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