Atomized Intranasal Ketorolac at 30 mg Versus 20 mg for the Treatment of Acute Pain in the Emergency Department

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTehran University of Medical Sciences

About this trial

This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac at 30 mg Versus 20 mg for the Treatment of Acute moderate and severe Pain in the Emergency Department.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-65 years

Weight > 50 kg

Able to provide informed consent

Acute pain (<48 hours) with verbally administered NRS≥4 (0-10 range, 0 = no - pain and 10 = worst imaginable pain)

Disqualifiers

Active peptic ulcer disease (PUD)

History of hypersensitivity to NSAIDs

Pregnancy and breastfeeding

Renal failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • 20mg intranasal ketorolac

    Drug

    20 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril

  • 30mg Intranasal Ketorolac

    Drug

    30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: 30mg Intranasal KetorolacActive comparator 1 intervention
Group B: 20mg intranasal ketorolacExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain score at 30 minutes

Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)

Time frame
30 minutes post-administration

Secondary outcomes

1

Pain score at 15 minutes

Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)

Time frame
15 minutes post-administration
2

Pain score at 45 minutes

Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)

Time frame
45 minutes post-administration
3

Pain score at 60 minutes

Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)

Time frame
60 minutes post-administration
4

Need for rescue analgesia

IV morphine 0.1 mg/kg will be available at 30 minutes in cases of patients request

Time frame
30 minutes post-administration

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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