Safety Study of Analgesia After Craniotomy Surgery With End Tidal CO2 Monitoring

Pain Clinical Trial

Official title:

Post Craniotomy Analgesia Safety Monitoring With ET CO2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327677
• Other study ID #: NA_00029336
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2011
• Last updated: August 29, 2016
• Start date: May 2011
• Est. completion date: May 2014

Study information

• Verified date: August 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, we want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

Description:

See brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult male and female, English speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for this study.

Exclusion Criteria:

• pregnant women

• patients with post operative neurological changes

• patients who remain intubated post-operatively

• patients who require the use of concomitant administration of sedatives

• patients who are unable to initiate a PCA bolus

• patients who are unable to communicate verbally

• patients who are allergic to fentanyl

• patients who have a history of narcotic abuse

• patients who have a history of chronic pain requiring opioids

• patients who have been in any investigational drug trial within 1 month of the treatment day

• patients who have chronic respiratory insufficiency

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Fentanyl
25-50 mcg every 20 minutes
• Fentanyl
20mcg/demand dose with an 8 minute lock out

Locations

Country	Name	City	State
United States	The Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate < 10 breaths per minute for greater than 2 minutes.		up to 24 hours	Yes
Secondary	oxygen saturation <90%, apnea > 30 secs., ET CO2 > 60, need for narcan, excessive somnolence		up to 24 hours	Yes