Phase 4
Completed N=77
Low Dose Peri-operative IV Ketamine for Chronic Post-surgery Pain Prevention
Chronic Postoperative Pain
Source: ClinicalTrials.gov NCT01296347 ↗
Enrolled (actual)
77
Serious AEs
22.1%
Results posted
Apr 2017
Primary outcomePrimary: Pain Score on Moving at 6 Weeks — 0; 1.5 units on a scale — p=0.33
◆ Published Evidence
Established
31citations · ~4 / year
Ketamine infusion for 96 hr after thoracotomy: Effects on acute and persistent pain.
Summary
This study will test the null hypothesis that low-dose ketamine given peri-operatively will have no effect on the development of chronic post-surgical pain, in patients undergoing thoracotomy or video assisted thoracic surgery (VATS) procedures
A double-blind, randomised placebo-controlled trial will be used to test the null hypothesis. Potential participants due to undergo either thoracotomy or video assisted thoracic surgery (VATS) will be identified by the collaborating thoracic surgeons in the out-patient department. Patients will be sent information about the study by post, prior to admission for surgery. If they are willing to participate, written consent will be sought on the ward preoperatively, where they will complete baseline measures of pain.
Patients will be randomised to receive an intravenous infusion of placebo (saline) or ketamine running at 0.1mg/kg/hour, starting 10 minutes prior to the surgical incision and continuing for the first three postoperative days (96 hours in total). Prior to starting the infusion a loading dose of ketamine (0.1 mg per kg) will be administered.
Linked Publications
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Ketamine infusion for 96 hr after thoracotomy: Effects on acute and persistent pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score on Moving at 6 Weeks |
0; 1.5 | 0.33 |
| SECONDARY Analgesic Consumption (Opioid) |
9; 0; 21; 17; 34; 9 | 0.71 |
| SECONDARY Sensory Testing |
— | — |
| SECONDARY Incidence of Side-effects, Nausea |
14; 17 | 0.47 |
| SECONDARY Incidence of Side Effect, Vomiting |
8; 8 | 1.00 |
| SECONDARY Incidence of Side Effect, Lightheaded |
5; 14 | 0.02 sig |
| SECONDARY Incidence of Side Effect, Vivid Dreams |
2; 13 | 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- All adult patients (18 years and above) who are undergoing either thoracotomy or video assisted thoracic surgery (VATS).
- Participants must be able to understand English.
Exclusion Criteria
- Patient refusal
- History of previous chronic thoracic pain
- Neuropathic pain (whatever the site), existing at time of recruitment
- Pre-operative analgesic treatments which include the following medications: strong opioids (step 3 analgesics), tricyclic antidepressants, venlafaxine, gabapentin, pregabalin, duloxetine, clonazepam or carbamazepine.
- Allergy to bupivacaine, morphine, paracetamol, tramadol, dihydrocodeine or ketamine.
Data sourced from ClinicalTrials.gov (NCT01296347) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.