Ketamine Improves Post-Thoracotomy Analgesia

Post Operative Pain Clinical Trial

Official title:

Ketamine Improves Post-Thoracotomy Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625911
• Other study ID #: TASMC-01-AW-114-CTIL
• Status: Completed
• Phase: N/A
• First received: February 8, 2008
• Last updated: February 28, 2008
• Start date: September 2001
• Est. completion date: March 2002

Study information

• Verified date: February 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Thoracotomy for lung tumor or for minimally invasive direct coronary artery bypass (MIDCAB) surgery, may be associated with debilitating pain. Ketamine was shown to enhance opioid antinociception and prevent opioid resistance. We hypothesize that ketamine given with morphine would lower morphine consumption and narcotic related side effects after thoracotomy and provide superior analgesia to morphine given alone.

Description:

We planned a prospective, randomomized, double blind study of 2 pain management protocols in consecutive patients undergoing thoracotomy for MIDCAB or lung tumor resection over a 6 month period. After patients emerged from a standardized general anesthetic and when objectively awake and complaining of pain >5/10 on a visual analogue pain scale, they were connected to an intravenous patient controlled analgesia regimen. The regimen was assigned randomly to be either morphine alone (1.5 mg per dose, lockout interval of 7 minutes) or morphine plus ketamine (1.0 mg morphine plus 5 mg ketamine per dose, same lockout interval). Rescue diclofenac was available to both groups. Follow-up lasted 4 hours.

We planned to monitor and compare pain scores, wakefulness scores, hemodynamic and respiratory parameters as well as total morphine consumption and incidence of side effects and complications. All monitoring and recording was done by blinded nurses and intensive care physicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Consecutive patients scheduled for elective minimally invasive direct coronary artery bypass (MIDCAB) or for lung resection via anterolateral thoracotomy during a 6-month period (Sep 2001-March 2002)

Exclusion Criteria:

Exclusion criteria were:

• American Society of Anesthesiologists (ASA) physical class =3, Emergency operations,

• Q-wave myocardial infarct occurring during the previous 3 weeks, or poor left ventricular function (e.g., ejection fraction [EF] <30% by echocardiography or angiography).

Other exclusion criteria were:

• A body mass index >35 kg/m2,

• Past or current neuropathy or psychological disturbances,

• The use of centrally active drugs,

• Chronic liver or renal failure requiring dialysis,

• A FEV1/FVC <70%,

• Allergy to ketamine, morphine or non steroidal anti inflammatory drugs (NSAIDs),

• Clotting abnormalities,

• A platelets count <70000/mm3,

• A white blood count <3000>14000/mm3,

• Uncontrolled diabetes mellitus or fasting blood glucose >250 g/dl,

• Evidence of sepsis or infection up to one week prior to randomization.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• morphine
intravenous patient controlled analgesia, standard protocol
• morphine ketamine
low dose ketamine added to 2/3 standard dose of morphine

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score		4 hours	No
Secondary	hemodynamic and respiratory parameters, side effects		4 hours	Yes