Randomised controlled trial of adjuvant promethazine for the relief of the pain of renal colic.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000376246

Enrollment

100

Registered

2009-05-28

Start date

2009-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Kidney stones [renal colic] can be a very painful condition. Current recommendations suggest non-steroidal anti-inflammatory agents [e.g. ketorolac, indomethacin] as first line treatment, although it is recognised that many patients also need strong painkillers such as morphine. A recent report has suggested that anti-histamine drugs [such as promethazine] may also be effective. The aim of this study is to compare the combination of promethazine/ indomethacin/ morphine against indomethacin/ morphine on the amount of pain reported and total dose of morphine needed for patients with kidney stone pain.

Interventions

Randomised to adjuvant promethazine 25mg IV single dose or not, in addition to non-steroidal anti-inflammatory drug [NSAID] [indomethacin 100mg oral or per rectum [PR]] and morphine 2.5mg intravenous [IV], with additional 2.5mg increments at 10 minutely intervals as required.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Adults aged 18-60 with clinical diagnosis of renal colic, confirmed by computed tomography scan within 48 hours of presentation

Exclusion criteria

Allergy to anti-histamines, NSAIDS, morphine Unable to consent Hypotension bllod pressure [BP] <100 Active peptic ulcer disease

Outcome results