To determine if treatment with betamethasone+Essex^® cream can decrease acute radiation dermatitis in patients with breast cancer receiving radiation as compared to two emollient creams.

Patients with breast cancer receiving radiation therapy were randomized 2:1:1 to three treatment groups—betamethasone+Essex cream, Essex cream, or Canoderm^® cream. Study creams were applied to the treated skin twice daily for five weeks starting the first week. Treatment continued for two weeks following completion of radiation. Physician/nurse examinations occurred weekly for the first five weeks of treatment.

• N = 102  
• MEDIAN AGE = 62 years
• AGE RANGE = 28–90 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Surgery for breast cancer, planned 3D radiation to 50 Gy
• OTHER KEY SAMPLE CHARACTERISTICS: Aged 18 years or older

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Ryhov County Hospital, Jonkoping, Sweden

• PHASE OF CARE: Active antitumor treatment

• Randomized, double-blinded

The Fitzpatrick skin type scheme I–IV  was used to classify patients as to skin type. Radiation dermatitis was scored using the Radiation Therapy Oncology Group (RTOG) scoring system. A colorimeter measured the redness of the skin at specific areas around the areola. Dryness of skin was measured using a Corneometer^®, with scores averaged using five specific locations. Itching, burning, and skin irritation were patient-scored using a visual analog scale (VAS) of 0–10. Quality of life was determined via the Dermatology Life Questionnaire Index on the first and fifth weeks of treatment. Post-radiation follow-up was by phone with symptoms assessed using VAS.

This study found that prophylactic treatment with betamethasone cream was superior to moisturizing cream for control of acute radiation dermatitis. Because prolonged treatment with topical steroids is known to be able to harm skin integrity, use was limited to seven weeks.

• Measurement validity/reliability questionable
• Other limitations/explanation: RTOG scoring of skin toxicity has not been tested for validity and reliability.

Because up to 90% of patients with breast cancer treated with adjuvant radiation have some degree of skin reaction, assessing and treating according to evidence-based practices is important. This study shows use of prophylactic steroid cream to reduce the severity of skin reaction in this group of patients.

To compare the antiemetic efficacy of second-generation 5HT3 receptor antagonists (RAs) (i.e., palonosetron) with older 5HT3 RAs (i.e., granisetron, azasetron, ramosetron) for controlling acute and delayed chemotherapy-induced nausea and vomiting (CINV) in addition to their effects on patients’ appetites

In this study, 103 patients receiving various chemotherapy regimens with highly emetogenic chemotherapy (HEC) (four regimens) or moderately emetogenic chemotherapy (MEC) (six regimens) were included. One 5HT3 RA (either granisetron, azasetron, ramosetron, or palonosetron) plus dexamethasone and/or aprepitant (a three-drug combination) was administered to 42 patients.

• N = 103
• MEDIAN AGE = 61.6 years
• MALES: 39.8%, FEMALES: 60.2%
• KEY DISEASE CHARACTERISTICS: Various cancers (most common were colorectal and breast)
• OTHER KEY SAMPLE CHARACTERISTICS: Receiving HEC (42 patients) or MEC (61 patients); experienced anticipatory CINV 24 hours before chemotherapy administration

• SITE: Single site                
• SETTING TYPE: Inpatient                    
• LOCATION: Ambulatory therapy center in Japan

• PHASE OF CARE: Active antitumor treatment

Prospective, comparative clinical trial

• Patient diaries were completed on days 1–5 using a 100 mm Visual Analog Scale (VAS) to assess CINV severity, the presence of daily vomiting episodes, and the effect of nausea on appetite level on a four-category scale (normal, appetite diminished because of nausea, food portions decreased because of nausea, and almost no food intake because of nausea).
• The efficacy endpoints were complete response (CR, no emetic episodes and no rescue therapy) and total control (TC, no emetic episodes, no rescue therapy, and no nausea and no appetite loss).

Palonosetron was more effective in controlling delayed CINV than other conventional 5HT3 RAs (i.e., granisetron). Palonosetron also was safe and was not associated with any severe adverse drug reactions.

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Risk of bias(sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results 
• Measurement/methods not well described
• Other limitations/explanation: No stratification of chemotherapy emetogenicity; various chemotherapy regimens; used more than one 5HT3 RA and different forms (i.e., oral, injection) of antiemetics; antiemetic doses and administration frequency not listed

Palonosetron was recommended as a 5HT3 RA over older 5HT3 RAs. The efficacy of palonosetron in the delayed phase was confirmed. In this study, patient appetite also improved.

To determine the effect of foot massage on pain after breast surgery and to provide guidance for nurses in nonpharmacologic interventions for pain relief

Patients were placed in the control or experimental group. The control group only received pain medications. In addition to receiving pain medications, the experimental group was given a 20-minute foot massage at the first complaint of pain. Pain and vital signs were assessed 5, 30, 60, 90, and 120 minutes after the first complaint of pain in both groups. The time periods were in sync between groups in regard to the first complaint of pain.

• N = 70 (sample size was calculated by power analysis)
• AGE = ≤ 18 years (40% between 41–60 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast surgery patients (included were excision of mass with either SLNBx or ALND, simple mastectomy, or modified radical mastectomy without surgical complications)
• OTHER KEY SAMPLE CHARACTERISTICS: No communication or mental disabilities; no expanders were placed during surgery; had at least one drain placed during surgery; no history of hypertension or need to take blood pressure on the foot;  had to express a pain level of four or higher

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: General department of breast surgery at a University Hospital in Istanbul Turkey between February 2007 and April 2008

• PHASE OF CARE: Active antitumor treatment

Quasi-experimental, nonrandomized, controlled, comparison study

• McGill Pain Questionnaire Short Form (MPQ-SF) including the visual assessment scale (0–10 cm line)

Foot massages with conventional pain medications can be effective in decreasing pain in patients after breast surgery. Nurses can easily use foot massage in patients without risk factors to decrease their pain. Nurses should provide nonpharmacologic techniques such as foot massage to decrease pain in patients after breast surgery.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results: Placebo effect of positive expectations that pain will be eliminated by an intervention can itself decrease pain
• Key sample group differences that could influence results: Four different types of surgery were included.
• Findings not generalizable
• Other limitations/explanation: The assessment of pain is very subjective.

Foot massage could be a practical addition to conventional pain management strategies to assist nurses in controlling postoperative pain. Foot massage is efficient, taking little time and costing little money. The initial cost of training could be quickly off set by the increase in patient satisfaction and better pain control. Including massage training in nursing schools would decrease the cost to institutions. Additional research in the use of massage in other patient populations is needed to help quantify massage as a pain management technique and nursing standard.

To evaluate the efficacy of aprepitant combined with conventional antiemetic therapy in patients receiving moderately emetogenic chemotherapy

5-HT₃ receptor antagonists were given 30 minutes prior to chemotherapy. Aprepitant was given orally at 125 mg on day 1 and 80 mg on days 2 and 3. Dexamethasone was given by infusion 30 minutes prior to chemotherapy. Patients were followed for five days. Results in these patients were compared to a control group that received only 5-HT₃ and dexamethasone.

• The study consisted of 52 patients.
• The mean age was 68.2, with a range of 34-83.
• The majority of the sample (73%) was male, and 27% was female.
• All patients had lung cancer.
   

The study was conducted at a single inpatient site in Japan.

All patients were in active antitumor treatment.

This was a retrospective study.

• The Common Terminology Criteria for Adverse Events was used.
• Complete response (CR) was defined as complete suppression of vomiting and no rescue medication.
• Food intake was measured.
• Chemotherapy completion rate was monitored.

• The CR for control of vomiting was 96% in controls and 100% in the group that was given aprepitant. 
• Complete suppression of nausea was reported as 89% among controls and 96% in the aprepitant group (p = 0.0043). 
• The amount of food intake was greater in the aprepitant group. 
• Completion of planned chemotherapy was higher in the aprepitant group (73.3% versus 88.2%, p = 0.042).

The addition of aprepitant to standard antiemtic therapy in patients receiving moderately emetogenic chemotherapy was associated with less nausea and vomiting and better food intake.

• The study had a small sample of fewer than 100 patients.
• A risk of bias exists because no control group, blinding, or random assignment was included.
• Rescue medications used were not described.  
• Whether differences in completion of the planned chemotherapy were related to chemotherapy-induced nausea and vomiting (CINV) or other toxicities was not clear.

Neurokinin 1 (NK1) receptor antagonists have been recommended for highly emetogenic chemotherapy (HEC); however, less evidence is available regarding their use with moderately emetogenic regimens (MEC).  This study suggests that the addition of NK1 to MEC is beneficial for reduction of CINV in this group of patients. Nurses can advocate for maximal symptom control to prevent CINV, one of the most severe adverse effects of chemotherapy.

To evaluate the efficacy and safety of aprepitant added to standard antiemetic regimens in high-dose chemotherapy for allogeneic hematopoietic stem cell transplantation

• N = 88  
• AVERAGE AGE = 47 years (control), 53 years (aprepitant)
• MALES: 57.1% (control); 60.9% (aprepitant), FEMALES: 42.9% (control); 39.1% (aprepitant)
• KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia, acute lymphoblastic leukemia, T-cell leukemia, lymphoma, myelodysplastic syndrome; sources of stem cells were related donors, placenta stem cells, bone marrow, unrelated donors, and cord blood
• OTHER KEY SAMPLE CHARACTERISTICS: Chemotherapies included cyclophosphamide, busulfan, fludarabine, and melphan as well as total body irradiation.

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Kyushu University Hospital in Japan

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care and palliative care 

Retrospective medical record review of electronic medical records

• Adverse effects were recorded by nurses in the medical records.

The use of aprepitant with granisetron was highly effective in decreasing vomiting and nausea in patients receiving hematopoietic stem cell transplantations. There was no increase in adverse events. There were therapeutic outcomes.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Selective outcomes reporting

The combination of granisetron and aprepitant was highly effective for chemotherapy-induced nausea and vomiting in patients receiving hematopoietic stem cell transplantations. Nurses should know that the combination did not increase side effects or affect engraftment.

To determine the effectiveness and safety of aprepitant in Japanese patients with hematologic malignancy receiving multiday chemotherapy

All patients were given 3 mg IV granisetron 30 minutes before chemotherapy. Corticosteroids were administered as part of the chemotherapy regimen.  In the aprepitant group, 125 mg was given orally on day 1; on following days, patients received 80 mg aprepitant daily. 

Data were collected via retrospective electronic medical records review for comparison of outcomes between those who received aprepitant versus those who did not. Nausea, vomiting, and adverse events were monitored daily and recorded in the medical record.

• The study consisted of 82 patients.
• The mean age was 47.5.
• The sample was 42.7% male and 57.3% female.
• All participants had hematologic malignancies.  Stem cell transplant patients were excluded.  All patients were receiving moderately or highly emetogenic chemotherapy in multiday regimens.

The study was conducted at a single inpatient site in Japan.

All patients were in active antitumor treatment.

This was a retrospective comparison.

Measurement tools were the Common Terminology for Adverse Events version 4.0 and complete response calculation.

• With aprepitant, the complete response (CR) rate for chemotherapy-induced nausea and vomiting (CINV) control was 76%, compared to 50% in those who did not receive aprepitant (p = 0.013). 
• The percentage of patients without any vomiting was significantly higher with aprepitant (p = 0.002).
• No significant differences were found between groups in prevalence of nausea. 
• Patients treated with regimens containing cytarabine had more CINV (p = 0.028).  In those patients receiving cytarabine 4 g/m² or more per day, CINV was poorly controlled for all patients. 
• Few adverse effects were found with aprepitant with the most common being malaise.

The study showed aprepitant to be safe and effective for CINV prophylaxis in this group of Japanese patients. Analysis suggested that cytarabine at a dosage of 4 g/m² or more per day should be considered highly emetogenic.

• The study had a small sample of fewer than 100 patients.
• A risk of bias exists because no blinding or random assignment was done.

This study adds to the body of evidence that demonstrates the safety and effectiveness of aprepitant for multiday chemotherapy by demonstrating effects in Japanese patients.

To evaluate the antiemetic effect and safety of aprepitant in combination with 5-HT3 receptor antagonist in patients undergoing autologous peripheral blood stem cell transplantation (auto-PBSCT)

This was a retrospective evaluation of patients who received conditioning high-dose chemotherapies prior to auto-PBSCT for hematologic malignancies comparing 26 consecutive patients who received antiemetic therapy that included both aprepitant and granisetron (the aprepitant group) between April 1, 2010, and January 31, 2010, and 22 patients who received granisetron alone (control group) between January 1, 2008, and March 31, 2010, before the introduction of aprepitant. In both groups, IV granisetron 3 mg was started 30 minutes prechemotherapy on day 1 and then repeated every 12 hours while receiving chemotherapy. In the aprepitant group, 125 mg of aprepitant was administered orally 60–90 minutes preadministration of the first moderately to highly emetogenic anticancer drug on day 1 and aprepitant 80 mg PO was given the following two days. Rescue medication including metoclopramide or hydroxyzine was used for breakthrough nausea or vomiting. A corticosteroid was not administered in either group for emetic control.

• N = 48              
• MEDIAN AGE = 52 years (range = 20–66 years)
• MALES:  58%, FEMALES:  42%
• KEY DISEASE CHARACTERISTICS: Patients with non-hodgkin lymphoma, multiple myeloma, hodgkin lymphoma, and leukemia. Conditioning regimens: MCEC (ranimustine 200 mg/m², carboplatin 300 mg/m², etoposide 500 mg/m², cyclophosphamide 50 mg/m²) or melphalan (100 mg/m²) +/– bortezomibor; LEED (etoposide 500 mg/m², cyclophosphamide 60 mg/m², melphalan 130 mg/m²). 
• OTHER KEY SAMPLE CHARACTERISTICS: Japanese descent

• SITE: Single-site  
• SETTING TYPE: Not specified  
• LOCATION: Japan

• PHASE OF CARE: Active antitumor treatment

Retrospective study design with a historical control.

Nausea, vomiting, and other adverse events (ADEs) were monitored twice daily (morning and evening), mainly by nurses, and recorded into EMRs. Primary endpoint was achievement of complete response (CR, defined as no emesis with only grades 1–2 nausea using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) during and until five days after the last chemotherapy dose was administered. Secondary endpoints included percent of patients without vomiting, percent without severe nausea, and the frequency of other ADEs. Severity of ADEs was classified by CTCAE version 4.0.

The percentage of patients who achieved CR in the aprepitant group was significantly higher than in the control group (42% versus 4.5%, p = 0.003). The percentage of patients without vomiting was higher in the aprepitant group (57%) versus the control group (4.5%; p < 0.001), and the percentage of patients without severe nausea was higher in the aprepitant group (58% versus 23%, p = 0.02) in the control group. There was no significant increase in ADEs when adding aprepitant to the antiemetic regimen.

The prophylactic administration of aprepitant significantly enhanced the effectiveness of antiemetic therapy without increasing the frequency and severity of ADEs in Japanese patients receiving high-dose chemotherapy prior to auto-PBSCT for hematologic malignancies.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions that would influence results are not described.
• Measurement/methods not well described
• Other limitations/explanation: The study design is limited in that it is a purely retrospective comparison of a very small group. There is limited of description of data collection. There was no report on the use of rescue medication in any of the analyses.

This study suggests that the addition of aprepitant to a 5-HT3 as prophylaxis for CINV in HEC regimens results in significant improvement in the control of CINV. This comparison of treatment regimens before and after the availability of aprepitant validates the added benefit of including a neurokinin 1 receptor antagonist to 5-HT3 in HEC regimens for improved CINV prophylaxis. Also, this antiemetic regimen did not incorporate the use of steroids, demonstrating a good level of efficacy with a 5-HT3 in addition to neurokinin 1 receptor antagonist.

To evaluate the efficacy of sublingual fentanyl orally disintegrating tablets (ODT) on breakthrough cancer pain; to assess the safety of sublingual fentanyl ODT and its impact on quality of life

Investigators followed patients through a 28-day observation period. Patients self-administered sublingual fentanyl ODTs on an as-needed basis for breakthrough pain episodes. The initial dose was determined by the clinician on the basis of previous treatment; the clinician titrated the dose as necessary. Patients used a questionnaire to record maximum breakthrough pain intensity, time to first effect, and time to maximum effect. Patients who had previously used breakthrough pain medication rated the effectiveness of the sublingual fentanyl ODTs in regard to speed, strength, and duration of action. During clinic visits on days 3, 7, 14, and 28, clinicians observed and recorded data about adverse events. Clinicians recorded measures of pain intensity at baseline and after 3, 7, and 14 days. Clinicians obtained anxiety and quality-of-life measures at baseline and at the end of the study.

• The sample was composed of 181 patients, and the study comprised 3,163 episodes of breakthrough pain.
• Mean patient age was 64.4 years. Age range was 35–89 years.
• Of all participants, 47.7% were female and 52.3% were male.
• Authors did not provide specific cancer-site information.
• At baseline, mean daily opioid use for background pain was 116.1 mg morphine equivalent. The range of daily opioid use for background pain was 60–240 mg.
• Mean pain intensity of background pain at baseline was 4.8. Mean number of breakthrough episodes was 2.7/day.
• The medications most commonly used for breakthrough pain were oral immediate-release liquid morphine, which 66% of patients used; oral transmucosal fentanyl citrate, which 13.2% of patients used; and oral immediate-release liquid hydromorphone, which 9.4% of patients used.

• Multisite
• Outpatient
• Germany

Prospective trial

• Numeric scale (0–10), to measure pain intensity
• Questionnaire, to measure breakthrough pain intensity maximum, time to first effect, and time to maximum effect
• Seven-point scale, to measure effect of study drug compared to that of previous medication in regard to speed of action, strength of action, duration of action, tolerability, and ease of handling
• Hospital Anxiety and Depression Scale (HADS)
• Modified Pain Disability Index (PDI)

With the study drug, breakthrough pain decreased signficantly (p < 0.00001), with mean pain intensity changing from 7.8 at baseline to 2.6. Patients reported that time to first effect was 10 minutes or less in 82.8% of episodes, less than 2 minutes in 19.4% episodes, and 2–5 minutes in 48.3% of episodes. Time to maximum effect was 30 minutes or less in 63.2% of episodes. In 83 patients who had previously used other medications for breakthrough pain, 87.7% said the study drug was better in speed of action; 85.7%, strength of action; 83.9%, duration of action; 88.6%, tolerability; and 87.3%, ease of handling. PDI scores decreased during the study (p < 0.0001). Prevalence of abnormal HADS scores declined. In regard to anxiety, 54.5% had abnormal scores at baseline; 1.6% had abnormal scores at the end of the study (p < 0.0001). In regard to depression, 70.3% had abnormal scores at baseline; 15.6% had abnormal scores at the end of the study (p < 0.0001). Mean dose per episode during the study was 400 mcg; dose range was 100–1600 mcg. Of all patients, 5.5% experienced at least one drug-related adverse event. The most common adverse events were nausea, somnolence, dizziness, and vomiting. At the end of the study, 84% of patients chose to continue taking sublingual fentanyl ODT.

Sublingual fentanyl ODT was effective in the treatment of breakthrough cancer pain. The drug had an acceptable safety profile and was associated with improvement in symptoms of anxiety and depression and improvement in pain-related disability scores.

• The study had a risk of bias due to no appropriate control group.
• Patients' recollection of experience with previous medications was the only basis of comparison regarding efficacy.
• Authors provide no information about missing data or patients' adherence to instructions about completing measurement assessments.
• Authors provide minimal demographic information about the sample.

Sublingual fentanyl ODT was a very effective and fast-acting treatment for breakthrough cancer pain. This drug appears to be an important addition to options for the management of breakthrough pain.

To determine the effectiveness of using antifungal therapy in conjunction with the diagnostic driven approach (DDA) in the management of invasive fungal infection (IFI) among patients undergoing allogeneic bone marrow transplantation (BMT)

Two strategies, DDA and antifungal prophylaxis, were used to diagnose and treat early IFI among allogeneic BMT patients. Two segments of 20 months included a preimplementation period in which medical records and laboratory statistics were used from admission up to six months. The intervention was the implementation of a DDA and the provision of antifungal prophylaxis. Prior to implementation, no routine antifungal prophylaxis was administered and the diagnosis of IFI was based on European Organization for Research and Treatment of Cancer (EORTC) criteria, including galactomannan assays. Antifungal agents were administered based on assay results. With the implementation of a new protocol, antifungal prophylaxis was given to those with graft-versus-host disease (GVHD), those treated with corticosteroid therapy, those with severe aplastic anemia, those undergoing cord blood transplantation, and those in which the standard diagnostic workup was deemed to be less effective. All patients were managed in high-efficiency particulate air (HEPA)-filtered rooms and housed in areas with limited access.

• N = 130   
• AGE = 35–45 years
• MALES: 38%, FEMALES: 28%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Malignant and benign, severe aplastic anemia
• OTHER KEY SAMPLE CHARACTERISTICS: Conditioning regimen (myeloablative or nonmyeloablative), presence of graft-versus-host disease (GVHD), neutropenia phase of absolute neutrophil count [ANC] < 500, and survival rates of three and six months. All had allogeneic hematopoietic stem cell transplantation (HSCT).

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Referral center for HSCT (Hadassah Medical Center), Israel

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Pre-post design in which two periods pre intervention and post intervention segments were analyzed

• Breakthrough IFI (not specifically defined)
• Antifungal use
• Diagnostic test utilization

A significant reduction in the cases of IFI (p = 0.051) was observed overall. The incidence of mold infection (aspergillosis) decreased substantially in the protocol period (p = 0.054). However, no change was noted in the survival rates and breakthrough fungal infection in the pre and post intervention phases.

The implementation of a clinical management protocol helped diagnose and treat early fungal infection and was associated with an overall reduction in the incidence of IFI.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Drug toxicity level and poor oral acceptability of the medication
• No differentiation between individuals who received antifungals prior to the protocol period in comparing outcomes
• Comparison to a historical cohort with potential related threats to validity

Nursing role is vital in identifying the key sign and symptoms of infection and to highlight them to decrease the rates of fungal infections, hence minimizing the mortality and morbidity rates overall. This study demonstrated that a standardized approach to prophylaxis was associated with reduced fungal infections.

To evaluate the effectiveness of gabapentin in treating acute postoperative pain in patients who have undergone craniotomy

For anticonvulsant prophylaxis, patients were randomized to one of two groups. One group received 1200 mg oral gabapentin daily (400 mg three times/day). The other received 300 mg oral gabapentin daily (100 mg three times/day). Patients took medications for seven days before surgery, as part of the surgical regimen, and postoperatively. All patients received postoperative morphine via patient controlled analgesia (PCA); the dose was titrated up to 0.1 mg/kg IV according to the pain rating on a visual analog scale (VAS). Postoperative follow-up included noting the VAS and Ramsay sedation scores, morphine consumption, and seizure activity or other adverse effects at 0, 15, and 30 minutes and at 1, 2, 4, 6, 12, 24, and 48 hours.

• The sample was composed of 75 patients.
• Mean patient age was 47 years.
• Of all patients, 52% were female and 48% were male.
• All patients had meningioma, glioma, or brain metastases and were undergoing elective supratentorial craniotomy for tumor resection. All patients had tumors with a diameter no larger than 30 mm and a rating of greater than or equal to 15 on the Glasgow coma scale.
• Excluded from the sample were patients taking tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, or neuroleptic or antiepileptic drugs.

• Single site
• Inpatient
• Turkey

Randomized parallel-group trial

• Visual analog scale, to measure pain
• Ramsay sedation scale
• Glasgow coma scale

• During the first postoperative hour and at all time points, postoperative VAS scores were significantly higher (p < 0.0001) for those on phenytoin than for those on gabapentin.
• Compared to patients on gabapentin, patients on phenytoin consumed significantly more morphine (p = 0.01), totally and cumulatively.
• During the first two hours after surgery, patients on gabapentin had significantly higher sedation scores (p < 0.05) than did patients on phenytoin.
• Two patients were removed from the study prior to surgery because of apparent side effects of gabapentin. Side effects included severe fatigue and severe dizziness.
• Patients on gabapentin required less perioperative anesthesia than did patients on phenytoin.
• Individuals on gabapentin had a longer time to tracheal extubation (16.6 minutes, SD = 22 minutes) compared to those on phenytoin (4.5 minutes, SD = 2 minutes) (p < 0.001).

Use of gabapentin as a prophylactic anticonvulsant was associated with lower postoperative opioid consumption and lower pain severity. Gabapentin was associated with higher sedation in the immediate postoperative period and a longer time to extubation.

• The study had a small sample size, with fewer than 100 patients.
• The study had a risk of bias due to no blinding.
• The specified use of gabapentin was in a very specific patient population. Findings may not be applicable to other groups of patients.

Gabapentin had significant analgesic effects in patients who had undergone craniotomy, but pain relief was associated with increased sedation and longer time to extubation. In patients undergoing neurosurgery, determining causes of increased sedation or delayed extubation can be difficult and critical. Sedation and delayed extubation can contribute to difficulties in clinical care. Future research should investigate the timing and dosage of gabapentin, with the goal of taking advantage of the drug's positive effects while minimizing negative side effects.