PMID- 17825695
OWN - NLM
STAT- MEDLINE
DCOM- 20071009
LR  - 20131121
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 29
IP  - 7
DP  - 2007 Jul
TI  - Single-dose intravenous tramadol for acute migraine pain in adults: a 
      single-blind, prospective, randomized, placebo-controlled clinical trial.
PG  - 1441-7
AB  - BACKGROUND: Tramadol, an atypical opioid, is a narcotic analgesic used for pain 
      management. A search of the current literature found no studies examining the 
      efficacy of intravenous tramadol on migraine pain. OBJECTIVE: The aim of this 
      study was to investigate the efficacy and tolerability of a single dose of 
      intravenous tramadol hydrogen chloride 100 mg in comparison with placebo in 
      patients presenting with migraine. METHODS: Adult migraineurs admitted 
      consecutively to the emergency department of the Kocaeli University Hospital were 
      enrolled in this single-blind (patients), prospective, randomized, 
      placebo-controlled clinical trial. Patients were randomized to receive a 
      30-minute infusion of either intravenous tramadol (n = 17; 100 mg in 100-mL 
      saline) or placebo (n = 17; 100-mL saline). Pain response was defined as a 
      decrease of visual analogue scale (VAS) (0-100 mm) score to <50% of the 
      pretreatment (baseline) value and a decrease of 4-point verbal scale (FPVS) score 
      (0 = none, 1 = mild, 2 = moderate, 3 = severe) to mild or none. Pain-free 
      response was defined as a decrease of both VAS and FPVS scores to 0. Pain was 
      assessed at baseline and at 30 minutes and 1 hour after treatment completion. 
      Migraine symptoms (eg, photophobia, phonophobia, nausea, vomiting) and adverse 
      events (AEs) were assessed at the same time. A follow-up was also conducted by 
      phone 24 hours after treatment. RESULTS: Forty-four migraineurs were screened and 
      34 (28 women and 6 men; mean [SD] age, 39.5 [10.4] years; all were white) were 
      enrolled in the study. Each group contained 11 patients with severe pain and 6 
      patients with moderate pain at baseline FPVS. At the end of 1 hour, pain response 
      was reported by significantly more patients in the tramadol group than in the 
      placebo group (12 [70.6%] vs 6 [35.3%]; P = 0.040). Pain-free response was 
      reported by 5 (29.4%) patients in the tramadol group and 2 (11.8%) patients in 
      the placebo group, although the difference was not statistically significant. 
      Symptoms associated with migraine were also relieved in all patients reporting 
      pain response. No AEs were observed. However, at the 24-hour follow-up, 1 patient 
      in the tramadol group reported transient blurred vision and dizziness within the 
      day of infusion. Headache recurrence was reported by 2 (16.7%) of the 12 patients 
      with pain response in the tramadol group and 1 (16.7%) of 6 patients with pain 
      response in the placebo group. CONCLUSIONS: Intravenous tramadol appeared to be 
      more effective than placebo in pain response rate at the end of the first hour. 
      The slow infusion of tramadol 100 mg in 100-mL saline solution was well tolerated 
      in this group of adult migraineurs.
FAU - Alemdar, Murat
AU  - Alemdar M
AD  - Department of Neurology, Medical Faculty, Kocaeli University Hospital, Kocaeli, 
      Turkey. drmuratalemdar@yahoo.com
FAU - Pekdemir, Murat
AU  - Pekdemir M
FAU - Selekler, Hamit Macit
AU  - Selekler HM
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Analgesics, Opioid)
RN  - 39J1LGJ30J (Tramadol)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Analgesics, Opioid/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Migraine Disorders/*drug therapy/physiopathology
MH  - Pain/*drug therapy/physiopathology
MH  - Pain Measurement
MH  - Prospective Studies
MH  - Tramadol/administration & dosage/adverse effects/*therapeutic use
EDAT- 2007/09/11 09:00
MHDA- 2007/10/10 09:00
CRDT- 2007/09/11 09:00
PHST- 2007/05/10 00:00 [accepted]
PHST- 2007/09/11 09:00 [pubmed]
PHST- 2007/10/10 09:00 [medline]
PHST- 2007/09/11 09:00 [entrez]
AID - S0149-2918(07)00209-3 [pii]
AID - 10.1016/j.clinthera.2007.07.017 [doi]
PST - ppublish
SO  - Clin Ther. 2007 Jul;29(7):1441-7. doi: 10.1016/j.clinthera.2007.07.017.