Research Critique Work Sheet

Quantitative Research

Prepared by Polly Ryan

Title of Study

The Effectiveness of Inhalation Isopropyl Alcohol VS Granisetron for the Prevention of Postoperative Nausea and Vomiting

Year of Publication

2007

Authors (list first two)

Teran, M and Hawkins, J.

__X___ Clinical experience

_____Research expertise

_____Prior publications

__X___Funding

_____Non-federal funding

__X___Federal funding

_____Non US governmental funding

Purpose

To compare the effectiveness of granisteron, the use of inhalation of isopropyl alcohol as prophylactic treatments for PONV with a control group.

Review of Literature

___X__Logical

_X____Clarity

__X___Current and comprehensive references

_____Pros/Cons presented

__X___Gaps in knowledge identified

_____ Importance of study

Comments:

Literature review involved 20 previous studies which focused on numerous topics: prediction, alternative methods, various medications, sex differences, menstrual cycle influence and children. The review itself started with explaining risk factors and went into what causes PONV. The article also explained the pathways that trigger this. They explain medications and that have been studied and that may help prevent PONV. They finish the review by describing the work done on IPA.

Research Question/Hypothesis

Evaluate treatment for post operative nausea and vomiting using IPA inhalation, granisteron and no treatment preoperatively, on arrival to PACU, at discharge from PACU, 6 hours after estuation, and 24 hours post intubation.

Study Design

___ Experimental/Randomized Clinical Trial

__X___Quasi-Experimental

_____Correlation

_____Descriptive

_____Program Evaluation

____Other

Sample and Setting

General description of participants (age, gender, etc.)

57 women, 18-50 years old

Important Inclusion and Exclusion Criteria:

Inclusion: ASA status of 1 or 2, scheduled for elective laparoscopic surgery.

Exclusion: nausea within 24 hours before surgery, allergy to IPA, laparoscopic which went to an open procedure, neuraxial block, decreased ability to breathe through the nose, history of alcohol abuse or disulfiram, pregnancy, menopause, emergency procedures.

Groups

_____True control group

_____Usual care group

___X__Intervention group(s)

Name or brief description of group:

Prophylactic inhalation of IPA

Name or brief description of group:

Prophylactic 0.1mg of granisetron

Name or brief description of group:

No prophylactic treatment

Type of Sample

Probability / Non-Probability
___X__ Simple Random Sampling
_____ Stratified Random Sampling
_____ Cluster
_____ Systematic / _____ Convenience
_____ Quota
_____ Purposive
_____ Snowball

Instruments

Measurement Tool / What did it measure? / Information about the measure: # or type questions; reliability or validity; inter-rater reliability; other
Demographic data / Age, LMP, height, weight, procedure type, physical status, history of smoking, motion sickness, and PONV / Factual data. Patient reported data.
Numeric rating scale / Nausea on a 0-10 scale / Self reported data. Similar to VAS scale.

Detailed Description of the Intervention

Specific Steps of the interventionPatients are randomly assigned to one of three groups. Given medication. Either 3 deep breaths of alcohol, .1 mg of grainistron 15-30 mins pre extubation, or nothing.

Knowledge and skills needed to deliver intervention (education, licensure, etc)

PACU RNs were trained, and blinded to the study. Investigators called the participants at home for follow up information.

Time to deliver/use the intervention

Depending on the intervention. Inhalation of alcohol, giving IV medication.

How frequently does it need to be delivered and what is the time interval in between delivery?

Not mentioned in the study. Only one inhalation of 3 deep breaths was given.

IRB Approval

___X__Yes

_____Does not mention

Threats to Validity

Threats to Internal Validity / Threats to External Validity
_____ History
_____ Maturation
___X__ Testing
_____ Instrumentation
_____ Mortality
_____ Selection Bias / ___X__ Novelty effects
_____ Interaction of history and treatment
__X___ Experimenter effect
_____ Measurement effect

Results

57 participants. Group one: 22, group 2:16, group 3:19. No differences in groups regarding demographics. 47 complained of nausea. No significance in regards to minutes to first episode, NRS at rescue treatment, number of episodes of PONV from 0-6 hours postoperatively, total number of episodes in 24 hour period. Was a difference in group one reporting more PONV episodes than the others. From the 6 to 24 hour period. NO correlation with smoking, motion sickness, or menstrual cycle.

Major Findings

Inhalation of alcohol is associated with increase number of episodes of PONV in 6 to 24 hour period. No correlation between menstrual period, smoking, history of motion sickness

Strengths and Weaknesses of Study

Strength / Weakness
Small focused group.
Randomized, PACU RNs were blinded. / Small sample size
Self reported data

Ranking of Scientific Merit

Agency for Health Care and Research

Evaluate each study – Assign a quality number to the study

Evaluate all articles within the collection of studies reviewed – Assign a Letter

•Types of Evidence

____Level 1 = meta-analysis

____ Level II = experimental studies

___X_ Level III = well-designed, quasi-experimental studies

____ Level IV = well designed, non-experimental studies

____ Level V = case reports and clinical examples