Morphine Versus Ketorolac in Renal Colic

Loredana Ghinea

Status and phase: Unknown; Phase 4

Conditions: Renal Colic

Treatments: Drug: Ketorolac; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT02782273

1-4627

Details and patient eligibility

About

The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in renal colic.

Full description

The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in renal colic.

The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : chlorhydrate drotaverine 40 mg, xilocaine 100 mg, both diluted in 100 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of renal colic
• grade 5 pain on a 1-10 visual pain scale

Exclusion criteria

• contraindications of ketorolac or opioids
• pregnancy
• allergies to ketorolac or opioids
• refusal of participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Ketorolac

Active Comparator group

Description:

The patients randomised to this arm they will receive 30 mg intravenous ketorolac.

Treatment:

Drug: Morphine

Morphine

Active Comparator group

Description:

The patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine.

Treatment:

Drug: Ketorolac