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N/A N=86 Randomized

Sedation and Pain (The Effect of IV Sedation on Pain Perception)

Pain

Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Pain Rating Change — -0.253; 0.762; -0.346 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
dexmedetomidine (Drug); midazolam (Drug); propofol (Drug)
Age
Adult · 19+ yrs
Sex
All
Sponsor
University of Alabama at Birmingham
Primary completion
Jan 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Rating Change
-0.253; 0.762; -0.346

Summary

The investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fMRI(objective).

Eligibility Criteria

Inclusion Criteria

Healthy subjects

  • 19 years or older able to follow study instructions

Exclusion Criteria

  • Age less than 19 or greater than 40
  • Pregnant female
  • Obesity (BMI > or =35)
  • Non-English speaking/reading participants
  • Sleep apnea
  • Pulmonary problems such as moderate or severe bronchial asthma
  • Cardiovascular problems such as hypertension
  • History of claustrophobia
  • Presence of a pacemaker, defibrillator, surgically placed metallic object (e.g., hip replacement)or other implanted device
  • Presence of an unremoved bullet or shrapnel in the body
  • Presence of a prosthetic that is not removable
  • Presence of a hearing aid needed for hearing
  • Head girth exceeding that of the head coil used in the magnet
  • Extensive metalwork on or in teeth, or irremovable false teeth or bridgework
  • Epilepsy
  • Chronic analgesic medication
  • Excessive tattoos (due to local skin heating with tattoos containing ferromagnetic particles)
  • History of surgery for which details are unavailable
  • Allery due to study drugs
  • History of drug abuse
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00853333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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