Safety Study of Analgesia After Craniotomy Surgery With End Tidal (ET) Carbon Dioxide (CO2) Monitoring

Johns Hopkins University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01327677

NA_00029336

Details and patient eligibility

About

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, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

Full description

See brief summary

Enrollment: 137 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

137 participants in 2 patient groups

Pro re nata (PRN) fentanyl

Active Comparator group

Description:

A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.

Treatment:

Drug: Fentanyl

Drug: Fentanyl

Intravenous Patient-controlled Analgesia (IVPCA) fentanyl

Active Comparator group

Description:

Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.

Treatment:

Drug: Fentanyl

Drug: Fentanyl