Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack

NCT01730326 | Completed Phase 4 DMC

• 1 other identifier: turkcuer 001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with acute migraine attack make up the majority of patients consulting the emergency services due to headache. The aim of treatment in the emergency service is to achieve a minimum level of undesirable side effects and to quickly relieve the pain which will not repeat after discharge from the emergency service. Ideal drug treatment contraindication should be at a minimum level and not trigger migraine. Paracetamol and Nonsteroidal anti-inflammatory drugs are often used in the treatment of migraine headache. Although narcotic analgesics provide effective and rapid analgesia, they have such side effects as hypotension, nausea and vomiting, drowsiness. In recent years, with the production of parenteral forms of non-steroidal anti-inflammatory painkillers, the analgesic efficacy of these drugs has been one of the topics of interest to researchers. Especially intravenous form of paracetamol is new yet compared to other Nonsteroidal anti-inflammatory drugs, and it is a drug with a wide safety margin and less incidence of side effects. The effectiveness of the Intravenous form of paracetamol and whether it can be an alternative to other analgesics is one of the major research topics today, and more study is needed on this subject. Both drugs are often used in emergency services to treat headache caused by acute migraine attack. Our aim is to compare the effectiveness of intravenous dexketoprofen with paracetamol in the treatment of the headache caused by acute migraine attack.

Conditions

Acute Migraine

Keywords

Headache; paracetamol; dexketoprofen; emergency department

Outcome Measures

Primary Outcomes (1)

• Reduction in visual analogue scale and Numeric Rating Scale

  The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.

  15 minutes interval

Secondary Outcomes (1)

• Adverse events

  30th minutes after

Other Outcomes (1)

• Reduction in verbal rating scale

  15 minutes interval

Study Arms (2)

Paracetamol

EXPERIMENTAL

Paracetamol which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.

Drug: Paracetamol

Dexketoprofen

ACTIVE COMPARATOR

Dexketoprofen which will be given after randomization will be diluted in serum physiologic and will be given as intravenous rapid infusion.

Drug: Dexketoprofen

Interventions

Paracetamol DRUG

1000 mg

Also known as: perfalgan 10 mg/ml

Paracetamol

Dexketoprofen DRUG

50 mg

Also known as: arveles 50 mg/2 ml

Dexketoprofen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a. Patients who are 18 years of age and older, and who agreed to participate in the study will be included in the study.

You may not qualify if:

• Patients having received analgesic in the last six hours,
• pregnant women,
• women of childbearing potential and not using birth control,
• those who do not agree to participate in the study,
• those under age of 18, those who have signs of peritoneal irritation,
• those who are allergic to drugs used in the study,
• hemodynamically unstable patients,
• patients with renal transplant,
• those who suffer from liver, kidney, cardiac and pulmonary insufficiency and others with systemic diseases,
• patients with vision problems and those who are illiterate will be excluded from the study.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Hospital, Emergency Department

Denizli, 20020, Turkey (Türkiye)

Location

Related Publications (3)

• Hewitt DJ, Martin V, Lipton RB, Brandes J, Ceesay P, Gottwald R, Schaefer E, Lines C, Ho TW. Randomized controlled study of telcagepant plus ibuprofen or acetaminophen in migraine. Headache. 2011 Apr;51(4):533-43. doi: 10.1111/j.1526-4610.2011.01860.x.

  PMID: 21457238 BACKGROUND

• Prior MJ, Codispoti JR, Fu M. A randomized, placebo-controlled trial of acetaminophen for treatment of migraine headache. Headache. 2010 May;50(5):819-33. doi: 10.1111/j.1526-4610.2010.01638.x. Epub 2010 Mar 5.

  PMID: 20236342 BACKGROUND

• Turkcuer I, Serinken M, Eken C, Yilmaz A, Akdag O, Uyan E, Kiray C, Elicabuk H. Intravenous paracetamol versus dexketoprofen in acute migraine attack in the emergency department: a randomised clinical trial. Emerg Med J. 2014 Mar;31(3):182-5. doi: 10.1136/emermed-2013-203044. Epub 2014 Jan 6.

  PMID: 24394884 DERIVED

MeSH Terms

Conditions

Headache; Emergencies

Interventions

Acetaminophen; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ibrahim Turkcuer, assoc. prof.

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pamukkale University denizli / TURKEY

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 21, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 21, 2012

Record last verified: 2012-11

Locations

TU (1)