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Acute Pain | Chronic Pain | General

Topical agents or dressings for pain in venous leg ulcers

Clinical bottom line:

there is no information on any intervention other than anaesthetic cream (EMLA) for persistent ulcer pain or pain on wound debridement. There is very preliminary evidence based on poor quality trials that EMLA cream applied 30-45 minutes before wound debridement may provide some pain relief. Further information is required to establish this, and to assess the effect of EMLA on healing rates and adverse effects.


Leg ulceration is a common health problem, which increases with age. Prevalence is estimated at approximately 0.1% to 0.2%, and the problem is recurring and chronic. Pain is frequently reported with leg ulcers, with between 17% and 65% of patients experiencing severe or continuous pain. However, pain relief is not a routine aspect of treatment.

Systematic review

Briggs M and Nelson EA. Topical agents or dressings for pain in venous leg ulcers (Cochrane review). The Cochrane Library. 1999(4).

Date review completed: May 1999

Number of trials included: 3

Number of patients: 134

Control group: no treatment or placebo

Main outcomes: pain and pain relief

Inclusion criteria were randomised controlled trials of topical analgesics/anaesthetics and dressings for the relief of venous leg ulcer pain; patient reported pain scores; patients of any age; leg ulcer not caused by arterial, diabetic or neuropathic, sickle cell or rheumatoid arthritis conditions; patients with persistent pain (i.e. pain in or around the site occurring without manipulation) and/or pain due to wound debridement (removal of necrotic tissue); patients with non-infected wounds; pain was a primary outcome of the trial; any language; any publication status.

Reviewers provided a descriptive summary of included trials as data pooling was not possible. Trials were assessed for risk of bias (i.e. poor methodology and design).

Findings

No trials were included for persistent chronic pain.

Treatment-related pain (e.g. pain on debridement)

Three small trials of poor methodology (or methodology unclear) were included. All looked at the use of local anaesthetic cream (EMLA 5%, 25 mg/g) applied 30 to 45 minutes before debridement.

One double blind trial of 69 patients looked at EMLA cream versus placebo cream. Reviewers note that the trial reported significant benefit of EMLA cream for pain.

One open trial of 43 patients looked at EMLA cream compared with a placebo cream. Each patient had eight debridements over two to nine days. Although finding suggest significant benefit of EMLA cream at debridement and at 4 hrs after debridement, reviewers point out that lack of blinding and methodological flaw of repeat assessments of the same patients suggests this information is not valid.

One trial of 22 patients looked at EMLA cream versus no treatment. Information was available in abstract form only, but suggests benefit of cream in visual analogue scale ratings of pain on debridement. However, poor methodology and small sample size (seven patients in control) bring into question the usefulness of this data.

Adverse effects

One trial reported that burning and itching were higher with removal of EMLA cream compared with placebo. Rates were 16/36 versus 10/33 (burning) and 10/36 versus 5/33 (itching).

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