Pain management after conservative treatment of extremity fractures, a randomized clinical trial

Fracture patients are prescribed a spectrum of analgesics to reduce pain. The
conscious understanding of this pain may be altered by a variety of factors,
including psychosocial factors. This could explain the apparent differences in
prescription habits for analgesic drugs, between American and Dutch orthopaedic
surgeons. There is currently no official (conservative) protocol for
pain-management after extremity fractures. The large differences between the
two countries emphasize how much there is to learn in this area of
investigation.
In this project we will study the effects of two different frequently used
analgesic regimens on pain relief, satisfaction with pain relief, and
disability after skeletal trauma. This study will compare a step
1-(acetaminophen (paracetamol)) with a step 2-based (acetaminophen + tramadol)
regimen. Current best evidence shows that it is highly possible that fracture
patients nowadays receive more and stronger painkillers than needed. This study
will be mandatory to provide a protocol for pain-management after extremity
fractures.
In addition to drug management, it would be helpful to find predictors for pain
intensity and disability to aid the physician in clinical decision-making and
assessing further management.

The primary objective of this study is to determine (differences in) patient
satisfaction with pain relief and pain intensity (Numeric Rating Scale) using a
step 1 vs. a step 2 based analgesic regimen.
The secondary objective is to determine predictors of pain intensity and
disability.
This will be mandatory to develop a useful protocol for pain-management.

This study is designed as a randomized clinical trial with short follow-up (2
weeks). Patients will be randomly assigned to either an acetaminophen based
pain regimen, or a tramadol based regimen. We will measure self-efficacy in
response to nociception and mood at enrollment. At time of follow-up (approx. 2
weeks) all patients will be given a questionnaire. They are asked to rate their
overall worst and average pain, the level of pain that would be acceptable to
them, overall satisfaction with pain relief (Numeric Rating Scale), and
disability. In addition, we will use a database to record age, sex,
trauma-site, fracture type, mechanism of injury, and comorbidity.
Intake will be *as needed* based, with a daily upper limit intake of: 1)
acetaminophen (4x 1g) 2) tramadol (4x 50-100mg).

This study does not provide immediate advantage for the participating patient.
For future patients however this study is beneficial, as it will evaluate the
effectiveness of the current pain management after conservative treatment after
extremity fractures. This study will likely reduce health costs. Participation
in this study is of low risk, since the patients will not receive more
medication then usual. It is not expected that patients will be undertreated,
since each subject will receive a frequently used regimen. In addition, our
previous prospective study showed adequate pain levels for patients who
received step 1 (WHO pain ladder) medication.